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

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

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

Official Title
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Mean Arterial Pressure Reduction During the First Ten Minutes After General Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion: Superiority Randomized Controlled Trial

Conditions
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Hypotension on Induction, Hypnotic Intoxication

Intervention / Treatment
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* Drug: Propofol
* Drug: Propofol Injection [Diprivan]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for general anesthesia; No contraindication for propofol. Exclusion Criteria: Data loss; Protocol violation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional bolus induction<br>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. | Drug: Propofol<br>* 2mg/kg single bolus<br>|
| Experimental: Target-controlled induction<br>Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained. | Drug: Propofol Injection [Diprivan]<br>* Tritiated Target-Controlled Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure after 2 minutes | Mean arterial pressure using non-invasive device | 2 minutes after general anesthesia induction | 
| Mean arterial pressure after 4 minutes | Mean arterial pressure using non-invasive device | 4 minutes after general anesthesia induction minutes after general anesthesia induction | 
| Mean arterial pressure after 6 minutes | Mean arterial pressure using non-invasive device | 6 minutes after general anesthesia induction minutes after general anesthesia induction | 
| Mean arterial pressure after 8 minutes | Mean arterial pressure using non-invasive device | 8 minutes after general anesthesia induction minutes after general anesthesia induction | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate after 2 minutes | Heart rate (pulse rate) using non-invasive device. | 2 minutes after general anesthesia induction | 
| Heart Rate after 4 minutes | Heart rate (pulse rate) using non-invasive device. | 4 minutes after general anesthesia induction | 
| Heart Rate after 6 minutes | Heart rate (pulse rate) using non-invasive device. | 6 minutes after general anesthesia induction | 
| Heart Rate after 8 minutes | Heart rate (pulse rate) using non-invasive device. | 8 minutes after general anesthesia induction | 
| Heart Rate after 10 minutes | Heart rate (pulse rate) using non-invasive device. | 10 minutes after general anesthesia induction | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |