Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.

Phase 4

Completed

• Conditions: Anesthesia, General; Anesthesia, Intravenous; Hemodynamics Instability
• Interventions: Drug: Propofol

• Registration Number: NCT03861364
• Lead Sponsor: Helse Fonna

Brief Summary

The study objective is to examine if a high propofol dose is non-inferior to a low dose in respect to hemodynamic stability in healthy patients during induction of general anesthesia with propofol and remifentanil.

Detailed Description

Typically, one or more adjuvant medications are administered to supplement induction of general anesthesia. When combining anesthetic drugs, the hypnotic effects are often synergistic. Propofol is associated with hypotension and bradycardia and used together with remifentanil or sedative agents it may give synergistic or additive sedative and hemodynamic effects.

Claeys (1988) and Fairfield (1991) examined the cardiovascular effects of propofol 2-2.5 mg/kg induction dose and found significant reductions i SBP and SVR and small changes in CO, SV and HR. De Wit (2016) examined hemodynamic changes in different steady state propofol serum concentrations, and found a dose dependent SBP reduction, reduction in resistance of arterial and systemic circulation and a reduction in mean systemic filling pressures (MSFP) indicative of a reduction in "stressed volumes". The effective dose (ED) 95% for loss of consciousness for propofol was determined to 1.75 mg/kg when used alone, and 1.38 mg/kg when used together with remifentanil 0.25 microg/kg/min (total induction dose 1.75 microg/kg remifentanil) in a study by Koh et al. We want to examine the hemodynamic effects of giving a low (1.4 mg/kg) vs a high (2.4 mg/kg) propofol dose combined with a moderate remifentanil dose (about 1.5 microg/kg).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Study Start: 2019-09-03
• Primary Completion: 2020-05-19
• Study Completion: 2020-05-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Healthy women
• Age 18-50 years
• Gynecological procedures
• General anesthesia

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Exclusion Criteria

• Pre-existing hypertension
• Diabetes for several years
• Ischemic heart disease
• Cerebrovascular disease
• Heart valve disease
• Verified cardiac arrhythmia
• Anaemia
• Kidney or hepatic disease
• Hypersensitivity for soya, eggs or peanuts
• Pregnancy
• Poor health state
• Illicit substance use
• BMI <20 or >35 kg/m2
• SBP >150 mmHg
• HR >100 beats/min

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Propofol	Propofol	High Propofol induction dose
Low Propofol	Propofol	Low Propofol induction dose

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure (SBP)	The first 7.5 minutes during induction of general anesthesia	Relative change of SBP (mmHg)
Heart rate (HR)	The first 7.5 minutes during induction of general anesthesia	Relative change of HR (beats)

Secondary Outcome Measures

Name	Time	Method
Stroke Volume (SV)	The first 7.5 minutes during induction of general anesthesia	Relative change of SV (ml/beat)
Cardiac Output (CO)	The first 7.5 minutes during induction of general anesthesia	Relative change of CO (litre/min)
Systemic Vascular Resistance (SVR)	The first 7.5 minutes during induction of general anesthesia	Relative change of SVR (dynes-sec/cm5/m2)

Trial Locations

Locations (1)

Kirurgisk Klinikk-Anestesi; 🇳🇴 Haugesund, Rogaland, Norway