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

Primary Purpose

Obese Patients, Laparoscopic Colorectal Surgery

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
base on Lean Body Mass Pattern
base on Actual Body Weight
obese patients
normal patients
Sponsored by
The First Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese Patients focused on measuring the lean body mass, cisatracurium, obese patients, deep neuromuscular blockade

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The First hosptial of Qinhuangdao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Sham Comparator

Experimental

Arm Label

Normal Real group

Normal Lean group

Obese Real group

Obese Lean group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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.
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
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.
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
Change in time during PACU(postanesthesia care unit)
recoding the duration of stay in PACU(postanesthesia care unit)
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".

Secondary Outcome Measures

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
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
Change in PaCO2 before and after pneumoperitoneum
arterial blood gas(ABG) was measured before and after pneumoperitoneum.Recording PaCO2 before and after pneumoperitoneum
Incidence of postoperative pain
Incidence of postoperative pain (shoulder, lumbar abdomen, arm)
Whether hypoxemia occurs after extubation
Observe the occurrence of hypoxemia after extubation

Full Information

First Posted
May 7, 2022
Last Updated
February 13, 2023
Sponsor
The First Hospital of Qinhuangdao
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1. Study Identification

Unique Protocol Identification Number
NCT05391958
Brief Title
Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients
Official Title
Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Qinhuangdao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Patients, Laparoscopic Colorectal Surgery
Keywords
the lean body mass, cisatracurium, obese patients, deep neuromuscular blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Real group
Arm Type
Sham Comparator
Arm Description
the medication group was given according to the actual weight of normal weight patients
Arm Title
Normal Lean group
Arm Type
Active Comparator
Arm Description
For normal weight patients, the medication group was given according to the lean body mass
Arm Title
Obese Real group
Arm Type
Sham Comparator
Arm Description
the medication group was given according to the actual weight of obese weight patients
Arm Title
Obese Lean group
Arm Type
Experimental
Arm Description
the medication group was given according to the lean body mass of obese weight patients
Intervention Type
Behavioral
Intervention Name(s)
base on Lean Body Mass Pattern
Other Intervention Name(s)
general anesthesia
Intervention Description
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
Intervention Name(s)
base on Actual Body Weight
Other Intervention Name(s)
base on Actual Body Mass Pattern
Intervention Description
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
Genetic
Intervention Name(s)
obese patients
Other Intervention Name(s)
laparoscopic colorectal surgery
Intervention Description
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
Intervention Name(s)
normal patients
Other Intervention Name(s)
laparoscopic colorectal surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in average dosing interval time
Description
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
Time Frame
during the surgery
Title
Change in Times of adding cisatracurium
Description
PTC was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,and recording the total times of injection.
Time Frame
during the surgery
Title
Change in total dosage of cisatracurium
Description
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
Time Frame
during the surgery
Title
Change in time of onset
Description
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.
Time Frame
through study completion, an average of 3 minute after induction
Title
Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection
Description
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
Time Frame
up to 1 hour after the surgery
Title
Change in time during PACU(postanesthesia care unit)
Description
recoding the duration of stay in PACU(postanesthesia care unit)
Time Frame
up to 2 hour after the surgery
Title
surgical rating scale(SRS)
Description
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".
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
The change of MAP (mean arterial pressure)
Description
Mean arterial pressure were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection
Time Frame
immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
Title
The change of HR(heart rate)
Description
the heart rate were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection
Time Frame
immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
Title
Change in PaCO2 before and after pneumoperitoneum
Description
arterial blood gas(ABG) was measured before and after pneumoperitoneum.Recording PaCO2 before and after pneumoperitoneum
Time Frame
before and after pneumoperitoneum during the surgery
Title
Incidence of postoperative pain
Description
Incidence of postoperative pain (shoulder, lumbar abdomen, arm)
Time Frame
Immediately after surgery and One day after surgery
Title
Whether hypoxemia occurs after extubation
Description
Observe the occurrence of hypoxemia after extubation
Time Frame
within 10 minutes after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PI qinshuang liu, master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
yuli guo, master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Chair
Facility Information:
Facility Name
The First hosptial of Qinhuangdao
City
Qinhuangdao
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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