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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05391958
Other study ID # 070733
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2021
Est. completion date July 3, 2022

Study information

Verified date January 2024
Source The First Hospital of Qinhuangdao
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 3, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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 ? ~ ?.
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 ? ~ ?.

Locations

Country Name City State
China The First hosptial of Qinhuangdao Qinhuangdao

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Incidence of postoperative pain Incidence of postoperative pain (shoulder, lumbar abdomen, arm) Immediately after surgery and One day after surgery
Secondary Whether hypoxemia occurs after extubation Observe the occurrence of hypoxemia after extubation within 10 minutes after extubation
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