Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion

NCT ID: NCT04291794

Last Updated: 2020-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-11-27

Brief Summary

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

Detailed Description

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To compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

Conditions

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Hypotension on Induction Hypnotic Intoxication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant and outcomes Assessor will not know group allocation.

Study Groups

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Conventional bolus induction

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

2mg/kg single bolus

Target-controlled induction

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

Group Type EXPERIMENTAL

Propofol Injection [Diprivan]

Intervention Type DRUG

Tritiated Target-Controlled Infusion

Interventions

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Propofol

2mg/kg single bolus

Intervention Type DRUG

Propofol Injection [Diprivan]

Tritiated Target-Controlled Infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Data loss;
* Protocol violation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brasilia University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gabriel Magalhaes Nunes Guimaraes

Voluntary professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriel MN Guimaraes, MSc

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Hospital Universitário de Brasilia

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Gabriel MN Guimaraes, MSc

Role: CONTACT

+5561996455997

Other Identifiers

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tccgui2019

Identifier Type: -

Identifier Source: org_study_id

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