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Completed

NCT Number: NCT05391958

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

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

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Key information

Conditions

Obese Patients Body Weight Digestive System Diseases Laparoscopic Colorectal Surgery Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Peritoneal Diseases Pneumoperitoneum Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First hosptial of Qinhuangdao

Qinhuangdao, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: general anesthesia

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.

Other names: base on Actual Body Mass Pattern

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.

Other names: laparoscopic colorectal surgery

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.

Other names: laparoscopic colorectal surgery

Primary outcomes

  1. Change in average dosing interval time

    Time frame: during 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

  2. Change in Times of adding cisatracurium

    Time frame: during 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.

  3. Change in total dosage of cisatracurium

    Time frame: during 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

  4. Change in time of onset

    Time frame: through 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.

  5. Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection

    Time frame: up 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

  6. Change in time during PACU(postanesthesia care unit)

    Time frame: up to 2 hour after the surgery

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

  7. surgical rating scale(SRS)

    Time frame: 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 outcomes

  1. The change of MAP (mean arterial pressure)

    Time frame: 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

  2. The change of HR(heart rate)

    Time frame: 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

  3. Change in PaCO2 before and after pneumoperitoneum

    Time frame: before and after pneumoperitoneum during the surgery

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

  4. Incidence of postoperative pain

    Time frame: Immediately after surgery and One day after surgery

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

  5. Whether hypoxemia occurs after extubation

    Time frame: within 10 minutes after extubation

    Observe the occurrence of hypoxemia after extubation

Sponsors and collaborators

Lead sponsor

The First Hospital of Qinhuangdao

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2022
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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