Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.

NCT03864094 | Completed Phase 4

• 2 other identifiers: 2019/3742019-000965-19
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability; Anesthesia, General; Anesthesia, Intravenous

Keywords

Cardiac Output (CO); Systolic Blood Pressure (SBP); Systemic Vascular Resistance (SVR); Heart Rate (HR); Stroke Volume (SV); Lithium Dilutional Cardiac Output (LiDCO); Minimal Invasive Hemodynamic Monitor; Propofol; Remifentanil; Ephedrine; Phenylephrine; Norepinephrine

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure (SBP)

  Change in SBP during induction as measured by the LiDCOplus monitoring system

  First 7,5 minutes from start of induction

• Heart Rate (HR)

  Change in HR during induction as measured by the LiDCOplus monitoring system

  First 7,5 minutes from start of induction

Secondary Outcomes (3)

• Stroke Volume (SV)

  First 7,5 minutes from start of induction

• Cardiac Output (CO)

  First 7,5 minutes from a start of induction

• Systemic Vascular Resistance (SVR)

  First 7,5 minutes from start of induction

Study Arms (4)

Ephedrine Propofol Remifentanil

ACTIVE COMPARATOR

Prophylactic Ephedrine

Drug: Ephedrine; Drug: Propofol; Drug: Remifentanil

Phenylephrine Propofol Remifentanil

ACTIVE COMPARATOR

Prophylactic Phenylephrine

Drug: Phenylephrine; Drug: Propofol; Drug: Remifentanil

Norepinephrine Propofol Remifentanil

ACTIVE COMPARATOR

Prophylactic Norepinephrine

Drug: Norepinephrine; Drug: Propofol; Drug: Remifentanil

Sodium chloride Propofol Remifentanil

SHAM COMPARATOR

NaCl Placebo

Drug: Sodium chloride; Drug: Propofol; Drug: Remifentanil

Interventions

Ephedrine DRUG

0,1 mg/kg

Also known as: Ephedrine Sulphate Injection

Ephedrine Propofol Remifentanil

Phenylephrine DRUG

1 microg/kg

Also known as: Phenylephrine Hydrocloride Injection

Phenylephrine Propofol Remifentanil

Norepinephrine DRUG

0,1 microg/kg

Also known as: Noradrenalin

Norepinephrine Propofol Remifentanil

Sodium chloride DRUG

0,1 ml/kg

Also known as: Sodium Chloride 0,9% injection

Sodium chloride Propofol Remifentanil

Propofol DRUG

2 mg/kg

Also known as: Propolipid

Ephedrine Propofol Remifentanil; Norepinephrine Propofol Remifentanil; Phenylephrine Propofol Remifentanil; Sodium chloride Propofol Remifentanil

Remifentanil DRUG

1,7 microg/kg

Also known as: Ultiva

Ephedrine Propofol Remifentanil; Norepinephrine Propofol Remifentanil; Phenylephrine Propofol Remifentanil; Sodium chloride Propofol Remifentanil

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Fonna: lead

Study Sites (1)

Helse Fonna, Haugesund Sykehus

Haugesund, Norway

Location

Related Publications (7)

• Fairfield JE, Dritsas A, Beale RJ. Haemodynamic effects of propofol: induction with 2.5 mg kg-1. Br J Anaesth. 1991 Nov;67(5):618-20. doi: 10.1093/bja/67.5.618.

  PMID: 1751277 BACKGROUND

• Kazmaier S, Hanekop GG, Buhre W, Weyland A, Busch T, Radke OC, Zoelffel R, Sonntag H. Myocardial consequences of remifentanil in patients with coronary artery disease. Br J Anaesth. 2000 May;84(5):578-83. doi: 10.1093/bja/84.5.578.

  PMID: 10844832 BACKGROUND

• Turner RJ, Gatt SP, Kam PC, Ramzan I, Daley M. Administration of a crystalloid fluid preload does not prevent the decrease in arterial blood pressure after induction of anaesthesia with propofol and fentanyl. Br J Anaesth. 1998 Jun;80(6):737-41. doi: 10.1093/bja/80.6.737.

  PMID: 9771299 BACKGROUND

• Al-Ghamdi A. Hydroxyethylstarch 6% preload does not prevent the hypotension following induction with propofol and fentanyl. Middle East J Anaesthesiol. 2004 Jun;17(5):959-68.

  PMID: 15449752 BACKGROUND

• El-Tahan MR. Preoperative ephedrine counters hypotension with propofol anesthesia during valve surgery: a dose dependent study. Ann Card Anaesth. 2011 Jan-Apr;14(1):30-40. doi: 10.4103/0971-9784.74397.

  PMID: 21196672 BACKGROUND

• Masjedi M, Zand F, Kazemi AP, Hoseinipour A. Prophylactic effect of ephedrine to reduce hemodynamic changes associated with anesthesia induction with propofol and remifentanil. J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):217-21. doi: 10.4103/0970-9185.130024.

  PMID: 24803761 BACKGROUND

• Sjoen GH, Hauge TH, Falk RS, Tonnessen TI, Langesaeter E. Haemodynamic Changes After Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine Versus Placebo During Induction of General Anaesthesia: A Randomised Trial. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70138. doi: 10.1111/aas.70138.

  PMID: 41144827 DERIVED

MeSH Terms

Interventions

Ephedrine; Acetaminophen; Phenylephrine; Norepinephrine; Sodium Chloride; Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Acetanilides; Anilides; Amides; Aniline Compounds; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gunnar Sjøen, MD

  Helse Fonna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anesthesiology

Model Details: Randomized, controlled, double-blind.

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 6, 2019
• Study Start: March 15, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be stored for 15 years after end of study, and may be shared during this time frame.
• Access Criteria: The data may be shared by contacting the Principal Investigator.

Locations

NO (1)