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

Not Applicable
Completed
Conditions
Obese Patients
Laparoscopic Colorectal Surgery
Interventions
Behavioral: base on Lean Body Mass Pattern
Behavioral: base on Actual Body Weight
Genetic: obese patients
Genetic: normal patients
Registration Number
NCT05391958
Lead Sponsor
The First Hospital of Qinhuangdao
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Obese Lean groupobese patientsthe medication group was given according to the lean body mass of obese weight patients
Normal Lean groupnormal patientsFor normal weight patients, the medication group was given according to the lean body mass
Obese Real groupobese patientsthe medication group was given according to the actual weight of obese weight patients
Normal Lean groupbase on Lean Body Mass PatternFor normal weight patients, the medication group was given according to the lean body mass
Obese Lean groupbase on Lean Body Mass Patternthe medication group was given according to the lean body mass of obese weight patients
Normal Real groupnormal patientsthe medication group was given according to the actual weight of normal weight patients
Obese Real groupbase on Actual Body Weightthe medication group was given according to the actual weight of obese weight patients
Normal Real groupbase on Actual Body Weightthe medication group was given according to the actual weight of normal weight patients
Primary Outcome Measures
NameTimeMethod
Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injectionup to 1 hour after the surgery

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 average dosing interval timeduring the surgery

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 cisatracuriumduring the surgery

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 time of onsetthrough study completion, an average of 3 minute after induction

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 total dosage of cisatracuriumduring the surgery

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 during PACU(postanesthesia care unit)up to 2 hour after the surgery

recoding the duration of stay in PACU(postanesthesia care unit)

surgical rating scale(SRS)during the surgery

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
NameTimeMethod
Incidence of postoperative painImmediately after surgery and One day after surgery

Incidence of postoperative pain (shoulder, lumbar abdomen, arm)

Whether hypoxemia occurs after extubationwithin 10 minutes after extubation

Observe the occurrence of hypoxemia after extubation

Change in PaCO2 before and after pneumoperitoneumbefore and after pneumoperitoneum during the surgery

arterial blood gas(ABG) was measured before and after pneumoperitoneum.Recording PaCO2 before and after pneumoperitoneum

The change of MAP (mean arterial pressure)immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection

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

the heart rate were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection

Trial Locations

Locations (1)

The First hosptial of Qinhuangdao

🇨🇳

Qinhuangdao, China

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