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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02194855
Enrollment
100
Registered
2014-07-18
Start date
2015-01-01
Completion date
2016-06-01
Last updated
2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C.Delivery; Surgery (Previous), Gynecological

Keywords

rocuronium, cisatracurium, pharmacokinetic

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.

Interventions

DRUGrocuronium

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

DRUGcisatracurium

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

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the blood flow in the right and middle hepatic veinsup to 9 monthsMeasurements 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

MeasureTime frameDescription
the plasma Concentration of rocuronium and cisatracuriumup to 9 monthsVenous 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

Other

MeasureTime frameDescription
pharmacodynamic comparison of rocuronium and cisatracuriumup to 9 monthsThis 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026