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

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT02194855
Collaborator
(none)
100
4
17

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis.
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: laparoscopic operation on rocuronium

according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.

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

Experimental: laparoscopic operation on cisatracurium

according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.

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

Experimental: conventional open surgery on rocuronium

according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.

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

Experimental: conventional open surgery on cisatracurium

according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.

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

Outcome Measures

Primary Outcome Measures

  1. the blood flow in the right and middle hepatic veins [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 Outcome Measures

  1. the plasma Concentration of rocuronium and cisatracurium [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 Outcome Measures

  1. pharmacodynamic comparison of rocuronium and cisatracurium [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fudan University

Investigators

  • Principal Investigator: Shaoqiang Huang, doctor, Obstetrics and Gynecology,Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tingting Wang, Tingting Wang, Fudan University
ClinicalTrials.gov Identifier:
NCT02194855
Other Study ID Numbers:
  • TingtingWang
First Posted:
Jul 18, 2014
Last Update Posted:
Aug 12, 2020
Last Verified:
Aug 1, 2020
Keywords provided by Tingting Wang, Tingting Wang, Fudan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2020