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

C.Delivery; Surgery (Previous), Gynecological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194855
• Other study ID #: TingtingWang
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2016
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• C.Delivery; Surgery (Previous), Gynecological

Intervention

Drug:
• rocuronium
Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus
• cisatracurium
cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pharmacodynamic comparison of rocuronium and cisatracurium	This study was undertaken to investigate the duration of action of 0.9 mg.kg-1 rocuronium or cisatracurium 0.15 mg.kg-1 administered during laparoscopic surgery compared with conventional open gynaecological surgery.Adductor pollicis train-of-four responses following ulnar nerve stimulation were monitored with mechanomyography.We recorded the time from the end of injection of rocuronium or cisatracurium to time to recovery of T1, and to recovery to 5% and 25% of baseline height	up to 9 months
Primary	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	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