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

Hypotension on Induction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04291794
• Other study ID #: tccgui2019
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: November 27, 2020

Study information

• Verified date: February 2020
• Source: Brasilia University Hospital
• Contact: Gabriel MN Guimaraes, MSc
• Phone: +5561996455997
• Email: gabrielmng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 27, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Scheduled for general anesthesia;

• No contraindication for propofol.

Exclusion Criteria:

• Data loss;

• Protocol violation.

Related Conditions & MeSH terms

• Hypnotic Intoxication
• Hypotension
• Hypotension on Induction

Intervention

Drug:
• Propofol
2mg/kg single bolus
• Propofol Injection [Diprivan]
Tritiated Target-Controlled Infusion

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasilia	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure after 2 minutes	Mean arterial pressure using non-invasive device	2 minutes after general anesthesia induction
Primary	Mean arterial pressure after 4 minutes	Mean arterial pressure using non-invasive device	4 minutes after general anesthesia induction minutes after general anesthesia induction
Primary	Mean arterial pressure after 6 minutes	Mean arterial pressure using non-invasive device	6 minutes after general anesthesia induction minutes after general anesthesia induction
Primary	Mean arterial pressure after 8 minutes	Mean arterial pressure using non-invasive device	8 minutes after general anesthesia induction minutes after general anesthesia induction
Primary	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	Heart Rate after 2 minutes	Heart rate (pulse rate) using non-invasive device.	2 minutes after general anesthesia induction
Secondary	Heart Rate after 4 minutes	Heart rate (pulse rate) using non-invasive device.	4 minutes after general anesthesia induction
Secondary	Heart Rate after 6 minutes	Heart rate (pulse rate) using non-invasive device.	6 minutes after general anesthesia induction
Secondary	Heart Rate after 8 minutes	Heart rate (pulse rate) using non-invasive device.	8 minutes after general anesthesia induction
Secondary	Heart Rate after 10 minutes	Heart rate (pulse rate) using non-invasive device.	10 minutes after general anesthesia induction
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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