Circulatory stability during start of general anesthesia administered with propofol an remifentanil. The effects of prophylactic ephedrine, phenylephrine, norepinephrine versus placebo.

Phase 1

• Conditions: Ephedrine, phenylephrine and norepinephrine are vasopressors used during anesthesia to treat hypotension. These agents raise blood pressure, but may have different effects on circulation as measured by changes in stroke volume, heart rate, cardiac output and total peripheral resistance. There is limited research of the circulatory effects during induction of general anesthesia with propofol and remifentanil.; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2019-000965-19-NO
• Lead Sponsor: Helse Fonna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-14
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

Woman
Gynecological procedure
Age 18-50 years
General anesthesia planned
Must have values as the following:
Systolic blood pressure < 150 mmHg, HR < 100 beats/min
Pregnancy test if in week of expected menstruation bleeding. Pregnancy test is not needed if using intrauterine anticonception device, implants and after female/male sterilization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pre-existing hypertension
Diabetes
Ischemic heart disease or cerebrovascular disease
Heart valve disease
Verified cardiac arrhythmia other than extrasystoles
Verfied anaemia with hemoglobin level below 9.0 gr/dl.
Kidney or hepatic disease
Hypersensitivity for propofol, soya, eggs or peanuts
Pregnancy
Poor health state
Illicit substance use
BMI <20 or >35 kg/m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In this trial we want to examine if there is any difference in haemodynamic stability when giving equipotent prophylactic injections of ephedrine 0,1 mg/kg, phenylephrine 1 mikrogrogr/kg, norepinephrine 0,1 mikrogr or NaCl 9 mg/ml (placebo) during induction of general anesthesia with propofol and remifentanil.<br>;Secondary Objective: Not applicable;Primary end point(s): The relative change of SBP (mmHg), HR (beats/min) and CO (litre/min) are the primary outcomes variables.<br>;Timepoint(s) of evaluation of this end point: From start until 7.5 minutes

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Relative change in SV (ml/beat) and SVR (dynes-sec/cm5/m2) are the secondary outcome variables.<br>;Timepoint(s) of evaluation of this end point: From start until 7.5 minutes