Skip to main content
Clinical Trials/EUCTR2019-000965-19-NO
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

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.

Registry
who.int
Start Date
March 14, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Helse Fonna

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

Similar Trials

Completed
N/A
Haemodynamic changes after induction of general anaesthesia as a predictor for ICU admission: a retrospective studyintensive care unit admission
DRKS00023854Klinik für Anästhesie und operative Intensivmedizin Zentrum für Schmerztherapiemedius KLINIK NÜRTINGEN Akademisches Lehrkrankenhaus der Universität Tübingen305
Completed
N/A
A study to compare the effectiveness of saddle spinal anesthesia (a technique) and traditional spinal anesthesia in providing anesthesia and maintaining the stability of haemodynamics in patients coming for transurethral resection of prostate surgery (TURP) for prostate enlargementSaddle anesthesiageriatric patients with genito urinary diseaseTURPSpinal anesthesia
TCTR20191122001Azeezia Institute of Medical Sciences & Research&#44; Kollam&#44; Kerala&#44; India90
Completed
N/A
A comparison of the hemodynamic stability between Inhaled general anesthesia and Total Intraveous Anesthesia (TIVA) undergoing coil embolizatio
JPRN-UMIN000036951Seoul National University Bundang Hospital2,500
Not Yet Recruiting
N/A
Factors Affecting the Hemodynamic Instability during Ventricular Rapid Pacing: Differential Predictors in Patients with Heart Failure with Preserved Ejection Fraction and Cardiac Resynchronized Therapy Device Implanted Patientsventricular tachycardia
JPRN-UMIN000028879Iwate Prefectural Central Hospital, Morioka, Iwate, Japan50
Completed
N/A
Factors Affecting the Hemodynamic Instability during Ventricular Rapid Pacing: Differential Predictors in Patients with Heart Failure with Preserved Ejection Fraction and Cardiac Resynchronized Therapy-Implanted Patients
JPRN-UMIN000028167Department of Cardiology, Iwate Prefectural Central Hospital100