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

NCT02194855 | Completed Phase 4 DMC

• 1 other identifier: TingtingWang
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

C.Delivery; Surgery (Previous), Gynecological

Keywords

rocuronium; cisatracurium; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the plasma Concentration of rocuronium and cisatracurium

  up to 9 months

Other Outcomes (1)

• pharmacodynamic comparison of rocuronium and cisatracurium

  up to 9 months

Study Arms (4)

laparoscopic operation on rocuronium

EXPERIMENTAL

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

laparoscopic operation on cisatracurium

EXPERIMENTAL

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

conventional open surgery on rocuronium

EXPERIMENTAL

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

conventional open surgery on cisatracurium

EXPERIMENTAL

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

Interventions

rocuronium DRUG

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

conventional open surgery on rocuronium; laparoscopic operation on rocuronium

cisatracurium DRUG

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

conventional open surgery on cisatracurium; laparoscopic operation on cisatracurium

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Interventions

Rocuronium; cisatracurium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shaoqiang Huang, doctor

  Obstetrics and Gynecology,Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tingting Wang

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 18, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 12, 2020

Record last verified: 2020-08