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

NCT05391958 | Completed

• 1 other identifier: 070733
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obese Patients; Laparoscopic Colorectal Surgery

Keywords

Laparoscopy; Cisatracurium; Obesity; Neuromuscular Blockade; Pneumoperitoneum; Pharmacology

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• The change of MAP (mean arterial pressure)

  immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection

• The change of HR(heart rate)

  immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection

• Change in PaCO2 before and after pneumoperitoneum

  before and after pneumoperitoneum during the surgery

• Incidence of postoperative pain

  Immediately after surgery and One day after surgery

• Whether hypoxemia occurs after extubation

  within 10 minutes after extubation

Study Arms (4)

Normal Real group

SHAM COMPARATOR

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

Behavioral: base on Actual Body Weight; Genetic: normal patients

Normal Lean group

ACTIVE COMPARATOR

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

Behavioral: base on Lean Body Mass Pattern; Genetic: normal patients

Obese Real group

SHAM COMPARATOR

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

Behavioral: base on Actual Body Weight; Genetic: obese patients

Obese Lean group

EXPERIMENTAL

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

Behavioral: base on Lean Body Mass Pattern; Genetic: obese patients

Interventions

base on Lean Body Mass Pattern 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.

Also known as: general anesthesia

Normal Lean group; Obese Lean group

base on Actual Body Weight 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.

Also known as: base on Actual Body Mass Pattern

Normal Real group; Obese Real group

obese patients 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.

Also known as: laparoscopic colorectal surgery

Obese Lean group; Obese Real group

normal patients 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.

Also known as: laparoscopic colorectal surgery

Normal Lean group; Normal Real group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

The First hosptial of Qinhuangdao

Qinhuangdao, China

Location

MeSH Terms

Conditions

Obesity; Pneumoperitoneum

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• PI qinshuang liu, master

  The First hosptial of Qinhuangdao

  STUDY DIRECTOR

• yuli guo, master

  The First hosptial of Qinhuangdao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 26, 2022
• Study Start: March 16, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 3, 2022
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)