Clinical trial NCT05391958: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obese Patients
Laparoscopic Colorectal Surgery
Keywords: Laparoscopy
Cisatracurium
Obesity
Neuromuscular Blockade
Pneumoperitoneum
Pharmacology
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2022-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in average dosing interval time
timeFrame: during the surgery
measure: Change in Times of adding cisatracurium
timeFrame: during the surgery
measure: Change in total dosage of cisatracurium
timeFrame: during the surgery
measure: Change in time of onset
timeFrame: through study completion, an average of 3 minute after induction
measure: Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection
timeFrame: up to 1 hour after the surgery
measure: Change in time during PACU(postanesthesia care unit)
timeFrame: up to 2 hour after the surgery
measure: surgical rating scale(SRS)
timeFrame: during the surgery
Secondary outcomes:
measure: The change of MAP (mean arterial pressure)
timeFrame: immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
measure: The change of HR(heart rate)
timeFrame: immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
measure: Change in PaCO2 before and after pneumoperitoneum
timeFrame: before and after pneumoperitoneum during the surgery
measure: Incidence of postoperative pain
timeFrame: Immediately after surgery and One day after surgery
measure: Whether hypoxemia occurs after extubation
timeFrame: within 10 minutes after extubation
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The First hosptial of Qinhuangdao
Study officials:
affiliation: The First hosptial of Qinhuangdao
name: PI qinshuang liu, master
role: STUDY_DIRECTOR
affiliation: The First hosptial of Qinhuangdao
name: yuli guo, master
role: STUDY_CHAIR
References: