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

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Colorectal Surgery; Obese Patients
• Intervention / Treatment: Behavioral: base on Actual Body Weight; Genetic: normal patients; Behavioral: base on Lean Body Mass Pattern; Genetic: obese patients

Detailed Description

According to the random number table method, one hundred and twenty patients who underwent elective laparoscopic colorectal surgery were divided into four groups (n=30): Normal weight patients according to lean body weight group(NL group), normal weight patients according to real weight group (NR group), obese patients according to lean body weight group(OL group), and obese patients according to real weight group(OR group).Intraoperative deep neuromuscular blockade (PTC≤2)was maintained in all four groups.The dosage of cisatracurium, the number of injections,time to effect,time to recovery from TOFr,time to recover TOFr（train-of-four rate） to 0.7 and 0.9,and time to stay in PCAU were recorded.The surgeon's satisfaction with the operative field and the average intraoperative pneumoperitoneum pressure were recorded at the time of pneumoperitoneum establishment,1 hour and 2 hours after pneumoperitoneum establishment.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Qinhuangdao, China
    • The First hosptial of Qinhuangdao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Laparoscopic Colorectal Surgery
• American Society of Anesthesiologists (ASA) grades I-III

Exclusion Criteria:

• Patients with heart, lung and other vital organ disorders
• Preoperative fluid and electrolyte disturbance
• Preoperative water and electrolyte disorders have a history of neuromuscular disease or take medications that have an impact on neuromuscular function
• There is a significant airway difficulty
• Refuse to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Normal Real group; the medication group was given according to the actual weight of normal weight patients	Behavioral: base on Actual Body Weight; 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.; Other Names: base on Actual Body Mass Pattern; Genetic: normal patients; 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.; Other Names: laparoscopic colorectal surgery
Active Comparator: Normal Lean group; For normal weight patients, the medication group was given according to the lean body mass	Genetic: normal patients; 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.; Other Names: laparoscopic colorectal surgery; Behavioral: base on Lean Body Mass Pattern; 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.; Other Names: general anesthesia
Sham Comparator: Obese Real group; the medication group was given according to the actual weight of obese weight patients	Behavioral: base on Actual Body Weight; 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.; Other Names: base on Actual Body Mass Pattern; Genetic: obese patients; 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.; Other Names: laparoscopic colorectal surgery
Experimental: Obese Lean group; the medication group was given according to the lean body mass of obese weight patients	Behavioral: base on Lean Body Mass Pattern; 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.; Other Names: general anesthesia; Genetic: obese patients; 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.; Other Names: laparoscopic colorectal surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao
• Investigators: Study Director: PI qinshuang liu, master, The First hosptial of Qinhuangdao; Study Chair: yuli guo, master, The First hosptial of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 3, 2022

Study Registration Dates

• First Submitted: May 7, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Obesity; Pharmacology; Laparoscopy; Cisatracurium; Neuromuscular Blockade
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 070733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No