Back to resultsMean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion
Primary Purpose
Hypotension on Induction, Hypnotic Intoxication
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Propofol
Propofol Injection [Diprivan]
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension on Induction
Eligibility Criteria
Inclusion Criteria:
- Scheduled for general anesthesia;
- No contraindication for propofol.
Exclusion Criteria:
- Data loss;
- Protocol violation.
Sites / Locations
- Hospital Universitário de Brasilia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional bolus induction
Target-controlled induction
Arm Description
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.
Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.
Outcomes
Primary Outcome Measures
Mean arterial pressure after 2 minutes
Mean arterial pressure using non-invasive device
Mean arterial pressure after 4 minutes
Mean arterial pressure using non-invasive device
Mean arterial pressure after 6 minutes
Mean arterial pressure using non-invasive device
Mean arterial pressure after 8 minutes
Mean arterial pressure using non-invasive device
Mean arterial pressure after 10 minutes
Mean arterial pressure using non-invasive device
Secondary Outcome Measures
Heart Rate after 2 minutes
Heart rate (pulse rate) using non-invasive device.
Heart Rate after 4 minutes
Heart rate (pulse rate) using non-invasive device.
Heart Rate after 6 minutes
Heart rate (pulse rate) using non-invasive device.
Heart Rate after 8 minutes
Heart rate (pulse rate) using non-invasive device.
Heart Rate after 10 minutes
Heart rate (pulse rate) using non-invasive device.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04291794
First Posted
February 26, 2020
Last Updated
February 28, 2020
Sponsor
Brasilia University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04291794
Brief Title
Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion
Official Title
Mean Arterial Pressure Reduction During the First Ten Minutes After General Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion: Superiority Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
September 25, 2020 (Anticipated)
Study Completion Date
November 27, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brasilia University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.
Detailed Description
To compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension on Induction, Hypnotic Intoxication
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participant and outcomes Assessor will not know group allocation.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional bolus induction
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Target-controlled induction
Arm Type
Experimental
Arm Description
Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
2mg/kg single bolus
Intervention Type
Drug
Intervention Name(s)
Propofol Injection [Diprivan]
Intervention Description
Tritiated Target-Controlled Infusion
Primary Outcome Measure Information:
Title
Mean arterial pressure after 2 minutes
Description
Mean arterial pressure using non-invasive device
Time Frame
2 minutes after general anesthesia induction
Title
Mean arterial pressure after 4 minutes
Description
Mean arterial pressure using non-invasive device
Time Frame
4 minutes after general anesthesia induction minutes after general anesthesia induction
Title
Mean arterial pressure after 6 minutes
Description
Mean arterial pressure using non-invasive device
Time Frame
6 minutes after general anesthesia induction minutes after general anesthesia induction
Title
Mean arterial pressure after 8 minutes
Description
Mean arterial pressure using non-invasive device
Time Frame
8 minutes after general anesthesia induction minutes after general anesthesia induction
Title
Mean arterial pressure after 10 minutes
Description
Mean arterial pressure using non-invasive device
Time Frame
10 minutes after general anesthesia induction minutes after general anesthesia induction
Secondary Outcome Measure Information:
Title
Heart Rate after 2 minutes
Description
Heart rate (pulse rate) using non-invasive device.
Time Frame
2 minutes after general anesthesia induction
Title
Heart Rate after 4 minutes
Description
Heart rate (pulse rate) using non-invasive device.
Time Frame
4 minutes after general anesthesia induction
Title
Heart Rate after 6 minutes
Description
Heart rate (pulse rate) using non-invasive device.
Time Frame
6 minutes after general anesthesia induction
Title
Heart Rate after 8 minutes
Description
Heart rate (pulse rate) using non-invasive device.
Time Frame
8 minutes after general anesthesia induction
Title
Heart Rate after 10 minutes
Description
Heart rate (pulse rate) using non-invasive device.
Time Frame
10 minutes after general anesthesia induction
Title
Bispectral Index after 2 minutes
Description
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.
Time Frame
2 minutes after general anesthesia induction
Title
Bispectral Index after 4 minutes
Description
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.
Time Frame
4 minutes after general anesthesia induction
Title
Bispectral Index after 6 minutes
Description
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.
Time Frame
6 minutes after general anesthesia induction
Title
Bispectral Index after 8 minutes
Description
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.
Time Frame
8 minutes after general anesthesia induction
Title
Bispectral Index after 10 minutes
Description
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.
Time Frame
10 minutes after general anesthesia induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Scheduled for general anesthesia;
No contraindication for propofol.
Exclusion Criteria:
Data loss;
Protocol violation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel MN Guimaraes, MSc
Phone
+5561996455997
Email
gabrielmng@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel MN Guimaraes, MSc
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário de Brasilia
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70000000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share at open database.
IPD Sharing Time Frame
After study ends
IPD Sharing Access Criteria
Open
Learn more about this trial
Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion
We'll reach out to this number within 24 hrs