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

NCT ID: NCT05391958

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2022-07-03

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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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.

Conditions

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Obese Patients Laparoscopic Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Normal Real group

the medication group was given according to the actual weight of normal weight patients

Group Type SHAM_COMPARATOR

base on Actual Body Weight

Intervention Type BEHAVIORAL

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.

normal patients

Intervention Type GENETIC

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.

Normal Lean group

For normal weight patients, the medication group was given according to the lean body mass

Group Type ACTIVE_COMPARATOR

base on Lean Body Mass Pattern

Intervention Type BEHAVIORAL

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.

normal patients

Intervention Type GENETIC

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.

Obese Real group

the medication group was given according to the actual weight of obese weight patients

Group Type SHAM_COMPARATOR

base on Actual Body Weight

Intervention Type BEHAVIORAL

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.

obese patients

Intervention Type GENETIC

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.

Obese Lean group

the medication group was given according to the lean body mass of obese weight patients

Group Type EXPERIMENTAL

base on Lean Body Mass Pattern

Intervention Type BEHAVIORAL

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.

obese patients

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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.

Intervention Type GENETIC

Other Intervention Names

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general anesthesia base on Actual Body Mass Pattern laparoscopic colorectal surgery laparoscopic colorectal surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PI qinshuang liu, master

Role: STUDY_DIRECTOR

The First hosptial of Qinhuangdao

yuli guo, master

Role: STUDY_CHAIR

The First hosptial of Qinhuangdao

Locations

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The First hosptial of Qinhuangdao

Qinhuangdao, , China

Site Status

Countries

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China

Other Identifiers

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070733

Identifier Type: -

Identifier Source: org_study_id

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