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

Phase 4

• Conditions: Hypotension on Induction; Hypnotic Intoxication
• Interventions: Drug: Propofol Injection [Diprivan]; Drug: Propofol

• Registration Number: NCT04291794
• Lead Sponsor: Brasilia University Hospital

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-28
• Last Update Submitted: 2020-02-28
• Study Start: 2020-03-01
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02
• Primary Completion: 2020-09-25
• Study Completion: 2020-11-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• Data loss;
• Protocol violation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Target-controlled induction	Propofol Injection [Diprivan]	Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.
Conventional bolus induction	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure after 2 minutes	2 minutes after general anesthesia induction	Mean arterial pressure using non-invasive device
Mean arterial pressure after 4 minutes	4 minutes after general anesthesia induction minutes after general anesthesia induction	Mean arterial pressure using non-invasive device
Mean arterial pressure after 6 minutes	6 minutes after general anesthesia induction minutes after general anesthesia induction	Mean arterial pressure using non-invasive device
Mean arterial pressure after 8 minutes	8 minutes after general anesthesia induction minutes after general anesthesia induction	Mean arterial pressure using non-invasive device
Mean arterial pressure after 10 minutes	10 minutes after general anesthesia induction minutes after general anesthesia induction	Mean arterial pressure using non-invasive device

Secondary Outcome Measures

Name	Time	Method
Heart Rate after 4 minutes	4 minutes after general anesthesia induction	Heart rate (pulse rate) using non-invasive device.
Heart Rate after 6 minutes	6 minutes after general anesthesia induction	Heart rate (pulse rate) using non-invasive device.
Heart Rate after 8 minutes	8 minutes after general anesthesia induction	Heart rate (pulse rate) using non-invasive device.
Bispectral Index after 4 minutes	4 minutes after general anesthesia induction	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.
Heart Rate after 2 minutes	2 minutes after general anesthesia induction	Heart rate (pulse rate) using non-invasive device.
Bispectral Index after 6 minutes	6 minutes after general anesthesia induction	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	8 minutes after general anesthesia induction	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.
Heart Rate after 10 minutes	10 minutes after general anesthesia induction	Heart rate (pulse rate) using non-invasive device.
Bispectral Index after 2 minutes	2 minutes after general anesthesia induction	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	10 minutes after general anesthesia induction	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.

Trial Locations

Locations (1)

Hospital Universitário de Brasilia; 🇧🇷 Brasilia, Distrito Federal, Brazil