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NCT03043157 Clinical Trial

Rocuronium Effective Dose for Laparoscopic Cholecystectomy

Muscle Relaxation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03043157
Other study ID # CAAE 60322116.2.0000.0025
Secondary ID
Status Completed
Phase Phase 3
First received February 2, 2017
Last updated September 12, 2017
Start date February 15, 2017
Est. completion date March 2, 2017

Study information
Verified date September 2017
Source Brasilia University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2, 2017
Est. primary completion date March 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- general anesthesia

Exclusion Criteria:

- deny participation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rocuronium
intravenous rocuronium infusion

Locations
Country Name City State
Brazil Hospital das Forças armadas Brasilia Distrito Federal

Sponsors (1)
Lead Sponsor Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Excellent laparoscopic conditions Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not 30 minutes
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