Rocuronium Effective Dose for Laparoscopic Cholecystectomy

Rocuronium ED50 for Excellent Laparoscopic Conditions for Cholecistectomy: Dose-finding Adaptative Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Muscle Relaxation
• Intervention / Treatment: Drug: rocuronium

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 700000000
      • Hospital das Forças Armadas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• general anesthesia

Exclusion Criteria:

• deny participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dose-finding group; 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.	Drug: rocuronium; intravenous rocuronium infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excellent laparoscopic conditions	Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not	30 minutes

Collaborators and Investigators

• Sponsor: Brasilia University Hospital
• Investigators: Principal Investigator: Gabriel MN Guimaraes, MsC, Universidade de Brasília

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): March 2, 2017
• Study Completion (Actual): March 2, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: CAAE 60322116.2.0000.0025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No