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

Study Overview
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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.

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

Conditions
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C.Delivery; Surgery (Previous), Gynecological

Intervention / Treatment
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* Drug: rocuronium
* Drug: cisatracurium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic operation on rocuronium<br>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<br>* Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus<br>|
| Experimental: laparoscopic operation on cisatracurium<br>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<br>* cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus<br>|
| Experimental: conventional open surgery on rocuronium<br>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<br>* Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus<br>|
| Experimental: conventional open surgery on cisatracurium<br>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<br>* cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rocuronium, cisatracurium, pharmacokinetic