NCT03043157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

15 days

First QC Date

February 2, 2017

Last Update Submit

September 12, 2017

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

  • Excellent laparoscopic conditions

    Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not

    30 minutes

Study Arms (1)

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

rocuroniumDRUG

intravenous rocuronium infusion

Dose-finding group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • general anesthesia

You may not qualify if:

  • deny participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Forças armadas

Brasília, Federal District, 700000000, Brazil

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Gabriel MN Guimaraes, MsC

    Universidade de Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Masking Details
Participant receives hypnotic (propofol) before we use the drug
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Dose-finding using Dixon's up-and-down adaptative clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 3, 2017

Study Start

February 15, 2017

Primary Completion

March 2, 2017

Study Completion

March 2, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)