EUCTR2019-000965-19-NO
Active, Not Recruiting
Phase 1
Haemodynamic stability during induction of general anesthesia with propofol and remifentanil: A randomized, controlled, double-blind study comparing equipotent prophylactic doses of ephedrine, phenylephrine, norepinephrine vs placebo.” - Vasopressor haemodynamics
Helse Fonna0 sites128 target enrollmentMarch 14, 2019
ConditionsEphedrine, 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Helse Fonna
- Enrollment
- 128
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Pre\-existing hypertension
- •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
- •Poor health state
- •Illicit substance use
- •BMI \<20 or \>35 kg/m2
Outcomes
Primary Outcomes
Not specified
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