Clinical trial NCT04291794: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypotension on Induction
Hypnotic Intoxication
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Data loss;
* Protocol violation.

Primary outcomes:
measure: Mean arterial pressure after 2 minutes
timeFrame: 2 minutes after general anesthesia induction
measure: Mean arterial pressure after 4 minutes
timeFrame: 4 minutes after general anesthesia induction minutes after general anesthesia induction
measure: Mean arterial pressure after 6 minutes
timeFrame: 6 minutes after general anesthesia induction minutes after general anesthesia induction
measure: Mean arterial pressure after 8 minutes
timeFrame: 8 minutes after general anesthesia induction minutes after general anesthesia induction
measure: Mean arterial pressure after 10 minutes
timeFrame: 10 minutes after general anesthesia induction minutes after general anesthesia induction
Secondary outcomes:
measure: Heart Rate after 2 minutes
timeFrame: 2 minutes after general anesthesia induction
measure: Heart Rate after 4 minutes
timeFrame: 4 minutes after general anesthesia induction
measure: Heart Rate after 6 minutes
timeFrame: 6 minutes after general anesthesia induction
measure: Heart Rate after 8 minutes
timeFrame: 8 minutes after general anesthesia induction
measure: Heart Rate after 10 minutes
timeFrame: 10 minutes after general anesthesia induction
measure: Bispectral Index after 2 minutes
timeFrame: 2 minutes after general anesthesia induction
measure: Bispectral Index after 4 minutes
timeFrame: 4 minutes after general anesthesia induction
measure: Bispectral Index after 6 minutes
timeFrame: 6 minutes after general anesthesia induction
measure: Bispectral Index after 8 minutes
timeFrame: 8 minutes after general anesthesia induction
measure: Bispectral Index after 10 minutes
timeFrame: 10 minutes after general anesthesia induction
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital Universitário de Brasilia
state: Distrito Federal
Study officials:
affiliation: Professor
name: Gabriel MN Guimaraes, MSc
role: PRINCIPAL_INVESTIGATOR
References: