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Back to Journal »Drug Design, Development and Treatment» Volume 15
Effects of different concentrations of esmolol on perioperative hemodynamics and analgesia in patients undergoing colectomy: a prospective randomized controlled study
Authors: Song Fei, Jin Yu, Li Peng, Zheng C, Zhao Xu
Published on December 14, 2021, the 2021 volume: 15 pages 5025-5033
DOI https://doi.org/10.2147/DDDT.S337201
Single anonymous peer review
Editor who approved for publication: Dr. Huang Tianhui
Fuxi Song,1 Yanwu Jin,1 Peng Li,1 Chao Zheng,2 Xin Zhao1 1Department of Anesthesiology, The Second Hospital of Qilu School of Medicine, Shandong University, Jinan, Shandong; 2Department of Breast Surgery, The Second Hospital of Qilu School of Medicine, Shandong University, Jinan, Shandong Communications Address: Zhao Xin, Department of Anesthesiology, Second Hospital of Qilu School of Medicine, Shandong University, No. 247 Beiyuan Street, Jinan City, Shandong Province, Zip Code 250033 Fax +86-531-88962544 Email [email protected] Purpose: This study aims to explore Ai The effect of Smolol on intraoperative hemodynamics and perioperative analgesia management. Methods: 125 patients undergoing colectomy were randomly divided into three groups. S group (normal saline group) was given normal saline 0.75 mL/kg/h for 5 min before anesthesia induction, maintaining 0.25 mL/kg/h; E1 and E2 groups were given 0.5 mg/kg and 1.0 mg/kg before anesthesia induction Smolol for 5 minutes, and maintain 0.5mg/kg/h and 2.0mg/kg/h respectively. Several parameters were measured, including hemodynamic change index (main outcome), intraoperative and postoperative analgesic use, and pain score. Results: The intubation response of E1 and E2 groups was significantly lower than that of S group (P=0.007, P=0.001), and the extubation response of E2 group was significantly lower than that of S group (P=0.007). The consumption of opioids in the E1 and E2 groups during the operation was significantly lower than that in the S group (P = 0.020 and 0.007). There was no significant difference in the incidence of adverse reactions between the three groups (P=0.368, 0.772). Conclusion: Infusion of esmolol 0.5 mg/kg and 1.0 mg/kg before intubation can effectively inhibit the intubation reaction, while maintaining only 2.0 mg/kg/h esmolol can reduce the incidence of extubation reaction. At the same time, esmolol can reduce the need for intraoperative opioids without increasing the risk of adverse reactions. Trial registration: ChiCTR1900024538, registration date is July 15, 2019, website: http://www.chictr.org.cn. Keywords: Esmolol, hemodynamics, analgesia, intubation response, extubation response
Surgical stress is a non-specific defense response, which is mainly manifested as sympathetic nerve excitement and enhancement of the hypothalamic-pituitary-adrenal axis (HPA or HTPA axis)1. Extubation and extubation can cause a strong stress response, leading to obvious hemodynamic instability and cardiovascular and cerebrovascular accidents, and bring great challenges to perioperative anesthesia and analgesia2.
Opioids are the main treatment for perioperative pain, but their use increases the incidence of respiratory complications, slows down normal gastrointestinal motility, and prolongs the hospital stay. 3,4 With the development of accelerated rehabilitation surgery (ERAS), reducing the use of perioperative opioids has become a common goal of anesthesiologists. The dosage of opioids should be strictly controlled as much as possible, not only to meet the needs of perioperative analgesia, but also to minimize the occurrence of adverse reactions. 5 It is unscientific to suppress the stress response of colectomy due to various factors, such as intestinal traction, stimulation surgery or anesthesia surgery. It is very important to seek the corresponding adjuvant therapy to suppress the stress response.
Esmolol is an ultra-short-acting, cardiac-selective β1-adrenergic receptor blocker. It has the characteristics of fast onset, short half-time, strong controllability, and few side effects. 6 It can effectively weaken the Adrenergic responses to stimulation during the perioperative period include tracheal intubation, intraoperative events, and tracheal extubation. Previous clinical studies have shown that perioperative infusion of esmolol can reduce opioid consumption and stress response. 7-9 However, in previous studies, the dose range of esmolol was wide. 10 Figueredo et al.'s meta-analysis results. 11 According to reports, the most effective way to inhibit adrenergic response during intubation is to use esmolol with a loading dose of 500 ug/kg/min, followed by continuous infusion of 200-300 ug /kg/min. In the study of Ratnani et al., 1.5 mg/kg esmolol 2 min before extubation can effectively inhibit hypertension and tachycardia. 12 However, we have not found relevant reference materials to support the effect of continuous intraoperative esmolol infusion on extubation. Considering that our patients are older, and many patients have a basic heart rate between 60 and 70 bpm, the safety range of esmolol is narrower than normal. Esmolol is an ultra-short-acting beta-blocker with a short action time in a single dose. Continuous administration can prolong the efficacy of esmolol and reduce the risk of bradycardia caused by a rapid single injection, which is often very dangerous for the elderly. Therefore, after fully considering the patient’s tolerance and the clinical experience of our anesthesiologists, we chose two relatively low doses to compare the hemodynamic and hemodynamic effects of intraoperative administration of esmolol on patients undergoing colectomy. The impact of perioperative analgesia.
This study is a single-center, prospective, randomized, controlled clinical trial conducted at the Second Hospital of Qilu School of Medicine, Shandong University, Jinan, Shandong, China. It was approved by the Ethics Committee of the Second Hospital of Shandong University with the approval number KYLL-2019(LW)009 , June 10, 2019. The study was prospectively registered at http://www.chictr.org.cn on July 15, 2019, with the identifier ChiCTR1900024538.
From July 20, 2019 to August 31, 2020, 152 consecutive patients aged 20-70, American Association of Anesthesiologists (ASA) physical condition I-III, and undergoing selective colectomy for colon cancer were identified. patient. 138 people were included and randomly assigned to three groups using computer-generated random numbers contained in sealed opaque envelopes. 14 people were excluded due to exclusion criteria; in addition, 4 patients were given severe hemodynamic fluctuations. Excluded; 9 cases were lost to follow-up; 125 patients were included in the final statistical analysis. The exclusion criteria are: patient refusal, pregnancy, bradycardia or atrioventricular block history; history of hypotension; history of bronchial asthma or severe chronic obstructive pulmonary disease (COPD); history of perioperative drug-related allergies, heart, liver, Patients with severe organ damage such as renal failure; body mass index (BMI) less than 18 or greater than 30 Kg/m2; patients who cannot cooperate with the test. All selected patients provided written informed consent.
All enrolled patients were divided into three groups according to random numbers generated by the computer. Before induction, the S group (normal saline group) was given 0.75 mL/kg/h of normal saline for 5 min and maintained at 0.25 mL/kg/h; the E1 and E2 groups were given 0.5 mg/kg and 1.0 mg/kg, respectively 5 minutes, and maintain 0.5mg/kg/h and 2.0mg/kg/h respectively. The esmolol (2 mL: 0.2 g*2, Qilu Pharmaceutical, China) used in this experiment was diluted with normal saline to 50 mL (8 mg/mL). The infusion of saline and esmolol was stopped immediately after extubation.
After applying the ASA standard monitor, propofol (1.5～2.0mg/kg) and sufentanil (0.3～0.5μg/kg) were used to standardize the induction of general anesthesia in the three groups. Cis-atracurium (0.2 mg/kg) facilitates tracheal intubation. After induction, catheterization of radial artery line and right internal jugular vein was given, and 60 mL 0.3% ropivacaine (30 mL on each side) was used for ultrasound-guided quadratus lumborum block (US-QLB). When the patient is undergoing surgical procedures such as skin dissection and intestinal traction, when the patient’s MAP or HR exceeds 20% or more of its baseline value, sufentanil will be given 0.1 ug/kg (if not sufficient within 10 minutes The improvement can be reused once). Intraoperative administration of vasoactive drugs (phenylephrine, ephedrine, nitroglycerin, urapidil, atropine or isoproterenol) to maintain a sufficient amount of opioids and blood pressure and heart rate fluctuations within 20%. If the MAP is higher than 120 mmHg or lower than 60 mmHg, and the HR is higher than 100 bpm or lower than 50 bpm, vasoactive drugs are also needed to correct the fluctuation. When hypotension or bradycardia recurs within 5 minutes after using vasoactive drugs to return to the normal range, it is recorded as refractory hypotension or bradycardia, and continuous use of vasoactive drugs is required to maintain normal MAP or HR. When intractable hypotension or bradycardia occurs, stop the test drug and switch to vasoactive drugs or other necessary measures such as blood transfusion and rapid infusion to improve the situation.
Sevoflurane (2~4% in 100% oxygen) is used for the maintenance of anesthesia, and the concentration is adjusted according to BIS to maintain between 40 and 60. During the maintenance period, give cis-atracurium (0.1 mg/kg/h) the judgment of the anesthesiologist. When placing the drainage tube, reduce the depth of anesthesia and use 3-5 ug/kg/h of remifentanil (adjusted according to MAP and HR). All patients entered the post-anaesthesia care unit (PACU) at least half an hour after extubation, and could not be discharged until their vital signs were stable.
All patients are equipped with a patient controlled analgesia (PCA) pump that delivers sufentanil 1 µg/kg, dexmedetomidine 1 µg/kg and palonosetron 0.25 mg at a basal rate of 3 mL/hour To 150 mL of the mixture, each 2 mL lock time is 20 minutes of the required dose. Start the PCA pump immediately after reaching the PACU. When the patient's numerical rating scale (NRS) is ≥4, the required dose of the PCA pump is given to relieve pain. And intravenous injection of flurbiprofen axetil 50 mg iv. And intramuscular injection of pethidine 50 mg im. For the Numerical Rating Scale (NRS) ≥ 4 or according to the patient's requirements, it is the first-line and second-line treatment for breakthrough pain, respectively. Palonosetron 0.25 mg intravenously as needed to control breakthrough nausea and vomiting.
Record the mean arterial pressure (MAP) and heart rate (HR) (T5) when entering the room (T1), after loading dose (T2), after induction of anesthesia (T3), 1 minute after intubation (T4), and 5 minutes after skin incision ), 1 hour after skin incision (T6), 2 hours after skin incision (T7) and 5 minutes after extubation (T8). When the MAP or HR at 5 minutes after intubation is more than 15% or more than the MAP or HR at 5 minutes after induction of anesthesia (before intubation), an intubation reaction is considered. At the same time, when the MAP or HR at 5 minutes after extubation is 15% or higher than that at 5 minutes before spontaneous breathing occurred before extubation, it is considered to be an extubation response. Record the incidence of intubation and extubation reactions respectively. NRS was recorded at 5 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, and 48 hours postoperatively (zero pain is 0, maximum pain is 10).
The main result is the incidence of intubation and extubation reactions. The second result is the occurrence of adverse events such as perioperative opioid consumption and pain score, intraoperative hemodynamics, postoperative emergency analgesics use, nausea, vomiting, refractory hypotension and bradycardia frequency.
The sample size is calculated based on the 30% expected difference in intubation and extubation responses from the previous study12 and our pre-test. For 80% study power (α = 0.05, β = 0.2), the total sample size is 114, with 38 patients per group (passed 15.0; NCSS statistical software, Caseville, Utah). Assuming a possible withdrawal rate of 20% (including loss of follow-up and discontinuation of testing due to severe hemodynamic instability), the final sample size was determined to be a total of 138 (46 patients per group). We applied the Visual Binning function of the Social Science Statistical Program (SPSS) to randomly divide 138 patients into three groups (33.33% for each group). The result of the grouping is wrapped in an opaque envelope. The anaesthetist in charge of data collection did not know the results of the grouping until the day of the operation.
The Social Science Statistical Program (SPSS) is used for statistical analysis of collected data. For scale (quantitative data), such as age, BMI, opioid dose, MAP, HR, we statistically describe them in the form of mean ± standard deviation, and use Kolmogorov-Smirnov to test their normal distribution and apply analysis of variance (ANOVA)) to test them. If the significance (P value) is <0.05, the data is analyzed by the least significant difference (LSD) test. For nominal (qualitative data), such as gender, intubation response, extubation response, we use frequency (percentage) to describe it statistically, and apply the chi-square test to verify its significance. If the P value is less than 0.05, a chi-square test between the two groups is performed. For ordinal numbers (rank data), such as NRS, we use the median (range) for statistical description. Kruskal-Wallis test is used to compare overall differences. If the P value is less than 0.05, Wilcoxon test is used for further analysis. All test results determined that the P value <0.05 was statistically significant.
A total of 125 patients completed the test (Figure 1). Figure 1 Flow chart of the inclusion, exclusion, and randomization of all patients.
Figure 1 Flow chart of the inclusion, exclusion, and randomization of all patients.
Statistical analysis of the basic and general conditions of patients during the operation showed that the difference was not statistically significant (P>0.05; Table 1). Table 1 Basic information and general conditions during surgery
Table 1 Basic information and general conditions during surgery
In the statistical analysis of MAP and HR, MAPT4, HRT2, HRT5, HRT6, HRT8 were significantly different among the three groups (P <0.05, Figure 2), but there was no statistical difference between the E1 group and the group E2 (P> 0.05, figure 2). The MAPT8 of the E2 group was significantly lower than that of the other two groups (P <0.05, Figure 2). The number of intubation reactions in group S was higher than that of the other two groups (P <0.05, Table 2). The incidence of extubation reaction in E2 group was significantly lower than that in S group and E1 group (P<0.05, Table 2). In the use of vasoactive drugs, only nitroglycerin in the S group was significantly more than that in the E1 and E2 groups (P<0.05, Table 2). Table 2 Hemodynamic fluctuations and vasoactive drugs Figure 2 Changes of MAP (A) and HR (B) in the three groups; scale variables are expressed as mean ± standard deviation; *P <0.05 between group S and group E1;# P <0.05 is between group S and group E2. Abbreviations: MAP, mean arterial pressure; heart rate, heart rate.
Table 2 Hemodynamic fluctuations and vasoactive drugs
Figure 2 Changes of MAP (A) and HR (B) in the three groups; scale variables are expressed as mean ± standard deviation; *P <0.05 between group S and group E1; #P <0.05 between group S and group E2 .
Abbreviations: MAP, mean arterial pressure; heart rate, heart rate.
In terms of the use of analgesics, the intraoperative opioid consumption of the E1 and E2 groups was significantly less than that of the S group (P<0.05, Table 3), but there was no significant difference between the two groups (P>0.05, Table 3). table 3). In addition, there was no significant difference in the amount of opioids and NRS in the three groups of patients within 48 hours after surgery (P>0.05, Table 3, Figure 3). There was no statistically significant difference in the incidence of adverse reactions among the three groups (P>0.05, Table 3). Table 3 Opioid doses and side effects Figure 3 NRS changes in the three groups; ordinal variables are described as median (range). No statistical significance was found (P> 0.05). Abbreviation: NRS, digital rating scale.
Table 3 Opioid dosage and side effects
Figure 3 NRS changes among the three groups; ordinal variables are described as median (range). No statistical significance was found (P> 0.05).
Abbreviation: NRS, digital rating scale.
From the results of this randomized controlled trial, it can be seen that continuous administration of esmolol during the perioperative period has a positive effect on the stability of hemodynamics. Before induction of anesthesia, esmolol 0.5 mg/kg (E1 group) and 1.0 mg/kg (E2 group) infusion can significantly reduce the incidence of intubation reactions without increasing the risk of hypotension. The dose of esmolol used in this study was lower than previous studies13,14. Through the comparison of multiple studies, we believe that low-dose esmolol has been able to significantly improve the increase in blood pressure caused by intubation. The main reason is that sufficient analgesics are given during induction of anesthesia, and propofol itself has a hypotensive effect, so the combination with a small amount of esmolol can inhibit the intubation response. In previous studies, most of the studies were about the effect of a single dose of esmolol on the extubation response,15,16. There are few articles about the effect of continuous administration of esmolol on the extubation response during surgery. Our experiment shows that continuous infusion of esmolol 2.0mg/kg/h can inhibit the extubation response, while esmolol 0.5mg/kg/h can only stabilize the HR after extubation without affecting MAP, and cannot reduce The occurrence of extubation reaction. In addition, the infusion of esmolol 2.0mg/kg/h can not completely inhibit the extubation reaction. This may be the result of a decrease or disappearance of anesthesia, plus surgical wound pain and irritation of tracheal extubation. Therefore, it is difficult to completely suppress the extubation reaction caused by various reasons by using esmolol alone.
In our research, we found that continuous administration of esmolol during the operation can suppress the significant increase in blood pressure during intubation, skin incision, and extubation (only continuous infusion of esmolol 2.0 mg/kg/h) Elevated, and can promote the heart rate to maintain a relatively low level during the relatively stable operating phase. On the one hand, it can reduce the increase in cardiac afterload and workload caused by increased blood pressure. On the other hand, lowering the heart rate can reduce myocardial oxygen consumption, thereby reducing the occurrence of cardiovascular accidents. A meta-analysis indicated that esmolol appears to be beneficial in preventing perioperative myocardial ischemia. 17 Another study proved that esmolol 0.5 mg/kg combined with nicardipine 20 ug/kg can effectively reduce cardiovascular response during rapid induction. 18 Esmolol can also be used for controlled hypotension in various operations, such as functional endoscopic sinus surgery (FESS), tympanoplasty and laparoscopic surgery. 19-21 These studies show that esmolol has a positive effect on maintaining intraoperative hemodynamic stability.
In addition, we found that esmolol can reduce the amount of intraoperative opioids, which is consistent with the previous results of Hamed et al. 22 In addition, the Gelineau study also proved that intraoperative infusion of esmolol can reduce the amount of opioids after surgery. 23 Esmolol itself has no analgesic effect, but some studies believe that its auxiliary analgesic effect is achieved by prolonging the action of opioids. 24 In this study, different doses of esmolol did not affect the amount of postoperative analgesics. It may be that all patients in this trial took QLB before surgery, which is a new type of trunk block method based on Transverse Abdominal Muscle Plane Block (TAPB). Blanco et al. found that QLB is closer to axons and sympathetic nerve trunks, and has obvious advantages over TAPB in terms of the duration of trunk analgesia and the reduction of visceral pain25. The consumption of opioids in the three groups was significantly reduced after surgery. Therefore, it is difficult to find their statistical significance. More importantly, we did not continue to use esmolol after extubation, so we could not find the sustained effect of esmolol on postoperative analgesia.
In the analysis of postoperative adverse reactions, it was found that esmolol did not increase the incidence of postoperative nausea and vomiting (PONV), persistent hypotension and bradycardia, which benefited from the ultra-short-acting effect of esmolol26 . Esmolol can reduce PONV, 27 this is mainly achieved by reducing the amount of opioids after surgery.
This experiment has the following limitations in the design process. First, quadratus lumborum block is performed after induction of anesthesia. Although the anaesthetist used the same method, we did not judge the scope and effect of QLB that may affect the results of the study. Secondly, this study did not collect the time of first gas and defecation, so the effect of esmolol on the recovery of gastrointestinal function after surgery has no theoretical basis. Third, we only selected a time point after intubation and extubation for MAP and HR statistics, which may obscure reliable estimates of the true incidence of intubation and extubation reactions. Finally, this study only compared MAP and HR at the same time point, and did not compare the hemodynamic fluctuations of patients in a short period of time. Monitoring MAP and HR every 5 minutes may be a better method.
Short-term infusion of esmolol 0.5 mg/kg or 1.0 mg/kg can effectively inhibit intubation reactions, but only continuous intraoperative infusion of esmolol 2.0 mg/kg/h can safely and effectively reduce the occurrence of extubation reactions . Esmolol 0.5mg/kg/h and 2.0mg/kg/h continuous infusion can reduce the amount of opioids during surgery without increasing the risk of adverse reactions.
ANOVA, analysis of variance; ASA, American Association of Anesthesiologists; BMI, body mass index; COPD, chronic obstructive pulmonary disease; ERAS, accelerated postoperative recovery; FESS, functional endoscopic sinus surgery; HPA (HTPA), hypothalamus-pituitary gland -Adrenal gland; HR, heart rate; LSD, least significant difference; MAP, mean arterial pressure; NCSS, digital calculation statistical system; NRS, digital rating scale; PACU, post-anaesthesia care unit; pass, efficacy analysis and sample size; PCA , Patient controlled analgesia; PONV, postoperative nausea and vomiting; QLB, quadratus lumborum block; SPSS, social science statistical program; TAPB, abdominal muscle plane block; US-QLB, ultrasound-guided quadratus lumborum block.
All data generated or analyzed during this research period are included in this published article. If you have a reasonable request, you can ask Professor Zhao Xin for further inquiries.
This study was approved by the Ethics Committee of the Second Hospital of Shandong University on June 10, 2019. The approval number is KYLL-2019(LW)009, which complies with the 1964 Declaration of Helsinki and its subsequent amendments or comparable ethical standards. The study was prospectively registered at http://www.chictr.org.cn on July 15, 2019, with the identifier ChiCTR1900024538. The informed consent of all participants was obtained.
All authors have read the manuscript, certify the validity and legality of the data and its interpretation, and agree to its publication.
The author is very grateful to Santosh Kumar Paidi from Johns Hopkins University in the United States for providing useful comments, suggestions and language editing for improving the manuscript. Zheng Chao thanked the Shandong Taishan Scholars Program (tsqn201812135) for its support. We would like to thank all participants who participated in the research for their cooperation.
The authors declare that they have no competing interests.
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