Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients

Study Overview
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Brief Summary
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To observe the pharmacodynamics of intravenous injection of cisatracurium to maintain deep neuromuscular blockade in obese patients with lean body mass in laparoscopic colorectal surgery

Detailed Description
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A total of 116 patients selected for laparoscopic colorectal surgery from March 2021 to June 2022 were randomly divided into four groups (n=29) : For normal weight patients, the medication group was given according to the lean body mass (NL group), the medication group was given according to the actual weight of normal weight patients (NR group), the medication group was given according to the lean body mass of obese weight patients (OL group), and the medication group was given according to the actual weight of obese weight patients (OR group). All the four groups maintained intraoperative deep neuromuscular blockade(PTC≤2). The dosage of cisatracurium, time to effect, time to recovery from four clusters of stimuli, recovery index, extubation time, and time to stay in PCAU(postanesthesia care unit) were recorded.

Official Title
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Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients

Conditions
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Obese Patients, Laparoscopic Colorectal Surgery

Intervention / Treatment
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* Behavioral: base on Lean Body Mass Pattern
* Behavioral: base on Actual Body Weight
* Genetic: obese patients
* Genetic: normal patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) grades I-III Exclusion Criteria: Patients with heart, lung and other vital organ disorders Refuse to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Normal Real group<br>the medication group was given according to the actual weight of normal weight patients | Behavioral: base on Actual Body Weight<br>* PTC was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on actual body weight once when PTC > 2.<br>* Other names: base on Actual Body Mass Pattern;Genetic: normal patients<br>* normal patients with elective laparoscopic colorectal surgery whose body mass index (BMI) 18-24 were selected,and American Society of Anesthesiologists (ASA) grade Ⅰ   Ⅲ.<br>* Other names: laparoscopic colorectal surgery;|
| Active Comparator: Normal Lean group<br>For normal weight patients, the medication group was given according to the lean body mass | Behavioral: base on Lean Body Mass Pattern<br>* PTC(post-tetanic count) was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on lean body weight mass pattern once when PTC > 2.<br>* Other names: general anesthesia;Genetic: normal patients<br>* normal patients with elective laparoscopic colorectal surgery whose body mass index (BMI) 18-24 were selected,and American Society of Anesthesiologists (ASA) grade Ⅰ   Ⅲ.<br>* Other names: laparoscopic colorectal surgery;|
| Sham Comparator: Obese Real group<br>the medication group was given according to the actual weight of obese weight patients | Behavioral: base on Actual Body Weight<br>* PTC was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on actual body weight once when PTC > 2.<br>* Other names: base on Actual Body Mass Pattern;Genetic: obese patients<br>* obese patients with elective laparoscopic colorectal surgery were selected，and the inclusion criteria were as follows: age 18-65, body mass index (BMI) 30-35, waist circumference (WC) : female ≥80cm, male ≥90cm, and American Society of Anesthesiologists (ASA) grade Ⅰ   Ⅲ.<br>* Other names: laparoscopic colorectal surgery;|
| Experimental: Obese Lean group<br>the medication group was given according to the lean body mass of obese weight patients | Behavioral: base on Lean Body Mass Pattern<br>* PTC(post-tetanic count) was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on lean body weight mass pattern once when PTC > 2.<br>* Other names: general anesthesia;Genetic: obese patients<br>* obese patients with elective laparoscopic colorectal surgery were selected，and the inclusion criteria were as follows: age 18-65, body mass index (BMI) 30-35, waist circumference (WC) : female ≥80cm, male ≥90cm, and American Society of Anesthesiologists (ASA) grade Ⅰ   Ⅲ.<br>* Other names: laparoscopic colorectal surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average dosing interval time | PTC(post-tetanic count)was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,average dosing interval time was recorded | during the surgery | 
| Change in Times of adding cisatracurium | PTC was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,and recording the total times of injection. | during the surgery | 
| Change in total dosage of cisatracurium | PTC(post-tetanic count) was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,and recording the total dosage of total dosage of cisatracurium | during the surgery | 
| Change in time of onset | 0.15mg/kg (3ED95) cisatracurium was given to all groups according to actual body weight as induction dose. Tracheal intubation was performed in all groups when TOFr(train of four ratio)=0.recording the time during this process. | through study completion, an average of 3 minute after induction | 
| Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection | The recovery of TOF(train of four) was continue observed after surgery.Recording the time both when TOF(train of four) recovered to 0.7 and 0.9 | up to 1 hour after the surgery | 
| Change in time during PACU(postanesthesia care unit) | recoding the duration of stay in PACU(postanesthesia care unit) | up to 2 hour after the surgery | 
| surgical rating scale(SRS) | Surgical rating Scale (SRS) was evaluated by surgical surgeons at the beginning, 1h and 2h of surgery, with a range of 1 to 5, corresponding to extremely poor, poor, adequate, good and best. | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of MAP (mean arterial pressure) | Mean arterial pressure were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection | immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection | 
| The change of HR(heart rate) | the heart rate were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection | immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection | 
| Change in PaCO2 before and after pneumoperitoneum | arterial blood gas(ABG) was measured before and after pneumoperitoneum.Recording PaCO2 before and after pneumoperitoneum | before and after pneumoperitoneum during the surgery | 
| Incidence of postoperative pain | Incidence of postoperative pain (shoulder, lumbar abdomen, arm) | Immediately after surgery and One day after surgery | 
| Whether hypoxemia occurs after extubation | Observe the occurrence of hypoxemia after extubation | within 10 minutes after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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the lean body mass, cisatracurium, obese patients, deep neuromuscular blockade