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

NCT ID: NCT02194855

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2016-06-01

Brief Summary

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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

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Conditions

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C.Delivery; Surgery (Previous), Gynecological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

rocuronium

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

cisatracurium

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

rocuronium

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

cisatracurium

Intervention Type DRUG

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

Interventions

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rocuronium

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

Intervention Type DRUG

cisatracurium

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Tingting Wang

Tingting Wang

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaoqiang Huang, doctor

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynecology,Fudan University

Other Identifiers

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TingtingWang

Identifier Type: -

Identifier Source: org_study_id

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