NCT04291794

Brief Summary

To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 26, 2020

Last Update Submit

February 28, 2020

Conditions

Hypotension on InductionHypnotic Intoxication

Outcome Measures

Primary Outcomes (5)

  • Mean arterial pressure after 2 minutes

    Mean arterial pressure using non-invasive device

    2 minutes after general anesthesia induction

  • Mean arterial pressure after 4 minutes

    Mean arterial pressure using non-invasive device

    4 minutes after general anesthesia induction minutes after general anesthesia induction

  • Mean arterial pressure after 6 minutes

    Mean arterial pressure using non-invasive device

    6 minutes after general anesthesia induction minutes after general anesthesia induction

  • Mean arterial pressure after 8 minutes

    Mean arterial pressure using non-invasive device

    8 minutes after general anesthesia induction minutes after general anesthesia induction

  • Mean arterial pressure after 10 minutes

    Mean arterial pressure using non-invasive device

    10 minutes after general anesthesia induction minutes after general anesthesia induction

Secondary Outcomes (10)

  • Heart Rate after 2 minutes

    2 minutes after general anesthesia induction

  • Heart Rate after 4 minutes

    4 minutes after general anesthesia induction

  • Heart Rate after 6 minutes

    6 minutes after general anesthesia induction

  • Heart Rate after 8 minutes

    8 minutes after general anesthesia induction

  • Heart Rate after 10 minutes

    10 minutes after general anesthesia induction

  • +5 more secondary outcomes

Study Arms (2)

Conventional bolus induction

ACTIVE COMPARATOR

Hypnotic component of general anesthesia induction will be a single bolus of propofol 2mg/kg followed by turning on sevoflurane 2% at a fresh gas flow of 2L/min.

Drug: Propofol

Target-controlled induction

EXPERIMENTAL

Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.

Drug: Propofol Injection [Diprivan]

Interventions

PropofolDRUG

2mg/kg single bolus

Conventional bolus induction
Propofol Injection [Diprivan]DRUG

Tritiated Target-Controlled Infusion

Target-controlled induction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for general anesthesia;
  • No contraindication for propofol.

You may not qualify if:

  • Data loss;
  • Protocol violation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário de Brasilia

Brasília, Federal District, 70000000, Brazil

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gabriel MN Guimaraes, MSc

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel MN Guimaraes, MSc

CONTACT

+5561996455997gabrielmng@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant and outcomes Assessor will not know group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Voluntary professor

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 2, 2020

Study Start

March 1, 2020

Primary Completion

September 25, 2020

Study Completion

November 27, 2020

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Plan to share at open database.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After study ends
Access Criteria
Open

Locations

BR(1)