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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04291794

Enrollment

120

Registered

2020-03-02

Start date

2020-03-01

Completion date

2020-11-27

Last updated

2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypnotic Intoxication, Hypotension on Induction

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.

Interventions

DRUGPropofol

2mg/kg single bolus

DRUGPropofol Injection [Diprivan]

Tritiated Target-Controlled Infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Participant and outcomes Assessor will not know group allocation.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Data loss; * Protocol violation.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.
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.
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.
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.
Heart Rate after 10 minutes	10 minutes after general anesthesia induction	Heart rate (pulse rate) using non-invasive device.

Countries

Brazil

Contacts

Primary ContactGabriel MN Guimaraes, MSc

gabrielmng@gmail.com+5561996455997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026