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

Mean Arterial Pressure Reduction During the First Ten Minutes After General Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion: Superiority Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Hypotension on Induction; Hypnotic Intoxication
• Intervention / Treatment: Drug: Propofol; Drug: Propofol Injection [Diprivan]

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gabriel MN Guimaraes, MSc; Phone Number: +5561996455997; Email: gabrielmng@gmail.com

Study Locations

• Brazil
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70000000
      • Hospital Universitário de Brasília

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Data loss;
• Protocol violation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Propofol; 2mg/kg single bolus
Experimental: 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.	Drug: Propofol Injection [Diprivan]; Tritiated Target-Controlled Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate after 2 minutes	Heart rate (pulse rate) using non-invasive device.	2 minutes after general anesthesia induction
Heart Rate after 4 minutes	Heart rate (pulse rate) using non-invasive device.	4 minutes after general anesthesia induction
Heart Rate after 6 minutes	Heart rate (pulse rate) using non-invasive device.	6 minutes after general anesthesia induction
Heart Rate after 8 minutes	Heart rate (pulse rate) using non-invasive device.	8 minutes after general anesthesia induction
Heart Rate after 10 minutes	Heart rate (pulse rate) using non-invasive device.	10 minutes after general anesthesia induction
Bispectral Index after 2 minutes	Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.	2 minutes after general anesthesia induction
Bispectral Index after 4 minutes	Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.	4 minutes after general anesthesia induction
Bispectral Index after 6 minutes	Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.	6 minutes after general anesthesia induction
Bispectral Index after 8 minutes	Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.	8 minutes after general anesthesia induction
Bispectral Index after 10 minutes	Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.	10 minutes after general anesthesia induction

Collaborators and Investigators

• Sponsor: Brasilia University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): September 25, 2020
• Study Completion (Anticipated): November 27, 2020

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: tccgui2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Plan to share at open database.
• IPD Sharing Time Frame: After study ends
• IPD Sharing Access Criteria: Open
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No