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

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.

Study Overview

• Status: Completed
• Conditions: C.Delivery; Surgery (Previous), Gynecological
• Intervention / Treatment: Drug: rocuronium; Drug: cisatracurium

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the blood flow in the right and middle hepatic veins	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.	up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the plasma Concentration of rocuronium and cisatracurium	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	up to 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacodynamic comparison of rocuronium and cisatracurium	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	up to 9 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pharmacokinetic; rocuronium; cisatracurium
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium; Cisatracurium
• Other Study ID Numbers: TingtingWang