Rocuronium Effective Dose for Laparoscopic Cholecystectomy

Phase 3

Completed

• Conditions: Muscle Relaxation
• Interventions: Drug: rocuronium

• Registration Number: NCT03043157
• Lead Sponsor: Brasilia University Hospital

Brief Summary

This is an adaptative study where each participant's rocuronium dose will depend on the previous patient's response, being higher if it was not enough and lower if it was more than enough.

Detailed Description

Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax abdominal wall for laparoscopic surgery.

Rocuronium intubation dose can be enough for intubation but not last enough for excellent laparoscopic conditions. There is little variation in time from anesthesia induction to the end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help providing excellent conditions and fast track extubation.

Dixon's up-and-down method will guide this dose-finding study for the ED50.

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2017-02-15
• Primary Completion: 2017-03-02
• Study Completion: 2017-03-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• general anesthesia

Exclusion Criteria

• deny participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose-finding group	rocuronium	The first patient will receive rocuronium 0,6mg/kg. After that, every patient's dose will depend on the outcome of the previous patient. It will go up 0,1mg/kg if the laparoscopic conditions were not excellent or go down 0,1mg/kg otherwise.

Primary Outcome Measures

Name	Time	Method
Excellent laparoscopic conditions	30 minutes	Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not

Trial Locations

Locations (1)

Hospital das Forças armadas; 🇧🇷 Brasilia, Distrito Federal, Brazil