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Completed

NCT Number: NCT02194855

Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis

The investigators investigated whether laparoscopic versus open surgical approaches affected the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or cisatracurium.

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Key information

Conditions

C.Delivery; Surgery (Previous), Gynecological

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiology 1-2
  • BMI 18-30 kg.m-2
  • elective gynaecological operations under general anaesthesia

Exclusion criteria

  • cirrhosis
  • hepatitis
  • hepatoma
  • heart failure
  • arrhythmia
  • renal dysfunction
  • electrolyte disturbances
  • acid-base imbalances
  • neuromuscular disorders

Treatment and study plan

Rocuronium

Drug

Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus

Cisatracurium

Drug

cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus

Primary outcomes

  1. the blood flow in the right and middle hepatic veins

    Time frame: up to 9 months

    Measurements of the blood flow in the right and middle hepatic veins were performed at baseline and 1,5, 10, 20, 30min after insufflation of carbon dioxide or incise the skin as well as 1 and 5 min after deflation or close the wound.

Secondary outcomes

  1. the plasma Concentration of rocuronium and cisatracurium

    Time frame: up to 9 months

    Venous blood samples (3 ml) were taken 2 min prior to and at 5,30, 60 min following administration of rocuronium/cisatracurium.The aim of the present was to study the blood concentration of rocuronium/cisatracurium in laparoscopic surgery compared with conventional open gynaecological surgery

Other outcomes

  1. pharmacodynamic comparison of rocuronium and cisatracurium

    Time frame: up to 9 months

    This study was undertaken to investigate the duration of action of 0.9 mg.kg-1 rocuronium or cisatracurium 0.15 mg.kg-1 administered during laparoscopic surgery compared with conventional open gynaecological surgery.Adductor pollicis train-of-four responses following ulnar nerve stimulation were monitored with mechanomyography.We recorded the time from the end of injection of rocuronium or cisatracurium to time to recovery of T1, and to recovery to 5% and 25% of baseline height

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2014
Registry last updated
Aug 12, 2020

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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