Clinical trial

"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."

Name

2019/374

Description

In this trial the investigators want to examine if there is any difference in hemodynamic stability when giving equipotent prophylactic injections of ephedrine 0,1 mg/kg, phenylephrine 1 microg/kg, norepinephrine 0,1 microg/kg or sodium chloride (NaCl) 9 mg/ml during induction of general anesthesia with propofol and remifentanil.

Trial arms

Trial start

2022-03-15

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Ephedrine

0,1 mg/kg

Arms:

Ephedrine Propofol Remifentanil

Other names:

Ephedrine Sulphate Injection

Phenylephrine

1 microg/kg

Arms:

Phenylephrine Propofol Remifentanil

Other names:

Phenylephrine Hydrocloride Injection

Norepinephrine

0,1 microg/kg

Arms:

Norepinephrine Propofol Remifentanil

Other names:

Noradrenalin

Sodium chloride

0,1 ml/kg

Arms:

Sodium chloride Propofol Remifentanil

Other names:

Sodium Chloride 0,9% injection

Propofol

2 mg/kg

Arms:

Ephedrine Propofol Remifentanil, Norepinephrine Propofol Remifentanil, Phenylephrine Propofol Remifentanil, Sodium chloride Propofol Remifentanil

Other names:

Propolipid

Remifentanil

1,7 microg/kg

Arms:

Ephedrine Propofol Remifentanil, Norepinephrine Propofol Remifentanil, Phenylephrine Propofol Remifentanil, Sodium chloride Propofol Remifentanil

Other names:

Ultiva

Size

Primary endpoint

Systolic Blood Pressure (SBP)

First 7,5 minutes from start of induction

Heart Rate (HR)

First 7,5 minutes from start of induction

Eligibility criteria

Inclusion Criteria: * Healthy women * Age 18-50 years * Gynecological procedures * General anesthesia 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, double-blind.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Randomization made by a person not involved in trial in other ways. Allocation masked in sealed envelopes, stored in a locked cash box only opened by two drug preparing nurses not involved in patient care. Syringe labelled with patient identification (ID) (eg 04Vaso). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 99, 'type': 'ESTIMATED'}}

Updated at

2023-09-28

1 organization

6 products

4 indications

Indication

Anesthesia

Indication

Intravenous

Product

Remifentanil

Organization