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

Phase 4

Completed

• Conditions: C.Delivery; Surgery (Previous), Gynecological
• Interventions: Drug: rocuronium; Drug: cisatracurium

• Registration Number: NCT02194855
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Study Start: 2015-01-01
• Primary Completion: 2016-01-01
• Study Completion: 2016-06-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic operation on rocuronium	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.
conventional open surgery on cisatracurium	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.
conventional open surgery on rocuronium	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.
laparoscopic operation on cisatracurium	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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