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

Fudan University

Status and phase: Completed; Phase 4

Conditions: C.Delivery; Surgery (Previous), Gynecological

Treatments: Drug: cisatracurium; Drug: rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT02194855

TingtingWang

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

laparoscopic operation on rocuronium

Experimental group

Description:

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.

Treatment:

Drug: rocuronium

laparoscopic operation on cisatracurium

Experimental group

Description:

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.

Treatment:

Drug: cisatracurium

conventional open surgery on rocuronium

Experimental group

Description:

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.

Treatment:

Drug: rocuronium

conventional open surgery on cisatracurium

Experimental group

Description:

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.

Treatment:

Drug: cisatracurium