Rocuronium Effective Dose for Laparoscopic Cholecystectomy | NCT03043157

Studies
Rocuronium Effective Dose for Laparoscopic Cholecystectomy

NCT03043157

Sponsor

Brasilia University Hospital

Status

Completed

Last Update Posted

Sep 13, 2017Actual

Enrollment

30Actual

Phase

Phase 3

Conditions

Muscle Relaxation

Interventions

rocuronium

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2017Actual

Primary Completion Date

Mar 2, 2017Actual

Completion Date

Mar 2, 2017Actual

First Submitted Date

Feb 2, 2017

First Submission Date that Met QC Criteria

Feb 2, 2017

First Posted Date

Feb 3, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2017

Last Update Posted Date

Sep 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gabriel Magalhaes Nunes Guimaraes, Head of Anesthesiology, Brasilia University HospitalPrincipal Investigator

Lead Sponsor

Brasilia University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose-finding group	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rocuronium	Drug	intravenous rocuronium infusion	Dose-finding group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

general anesthesia

Exclusion Criteria:

deny participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel MN Guimaraes, MsC	Universidade de Brasilia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Forças armadas		Brasília	Federal District	700000000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided