Hemodynamics During Induction of General Anesthesia With Medium or Low Remifentanil Doses.

NCT03861377 | Completed Phase 4

• 2 other identifiers: 2019/3762019-000961-19
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial the investigators want to examine if there is any difference in hemodynamic stability during induction when comparing two low and a medium remifentanil dose and keeping propofol induction dose at about 2.0 mg/kg.

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; Remifentanil

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure (SBP)

  Change in systolic blood pressure during induction

  First 7,5 minutes from start of induction

• Heart Rate (HR)

  Change in heart rate during induction

  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 (3)

Remifentanil R2

ACTIVE COMPARATOR

Low dose Remifentanil induction dose (R2)

Drug: Remifentanil R2

Remifentanil R4

ACTIVE COMPARATOR

Medium dose Remifentanil induction dose (R4)

Drug: Remifentanil R4

Remifentanil R8

ACTIVE COMPARATOR

Medium dose Remifentanil induction dose (R8)

Drug: Remifentanil R8

Interventions

Remifentanil R2 DRUG

0,7 microg/kg

Also known as: Ultiva

Remifentanil R2

Remifentanil R4 DRUG

1,1 microg/kg

Also known as: Ultiva

Remifentanil R4

Remifentanil R8 DRUG

1,7 microg/kg

Also known as: Ultiva

Remifentanil R8

Eligibility Criteria

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

You may qualify if:

• Gynecological procedure
• Age 18-50 years
• General anesthesia planned
• Systolic blood pressure \< 150 mmHg, HR \< 100 beats/min

You may not qualify if:

• Pre-existing hypertension
• Diabetes
• Ischemic heart disease or cerebrovascular disease
• Heart valve disease
• Verified cardiac arrhythmia other than extrasystoles
• Verified 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

Sponsors & Collaborators

• Helse Fonna: lead

Study Sites (1)

Kirurgisk Klinikk Anestesi

Haugesund, Rogaland, 5504, Norway

Location

Related Publications (5)

• 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

• 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

• Guarracino F, Penzo D, De Cosmo D, Vardanega A, De Stefani R. Pharmacokinetic-based total intravenous anaesthesia using remifentanil and propofol for surgical myocardial revascularization. Eur J Anaesthesiol. 2003 May;20(5):385-90. doi: 10.1017/s0265021503000589.

  PMID: 12790210 BACKGROUND

• Zaballos M, Jimeno C, Almendral J, Atienza F, Patino D, Valdes E, Navia J, Anadon MJ. Cardiac electrophysiological effects of remifentanil: study in a closed-chest porcine model. Br J Anaesth. 2009 Aug;103(2):191-8. doi: 10.1093/bja/aep131. Epub 2009 May 20.

  PMID: 19457895 BACKGROUND

• Hayashi K, Tanaka A. Effect-site concentrations of remifentanil causing bradycardia in hypnotic and non-hypnotic patients. J Clin Monit Comput. 2016 Dec;30(6):919-924. doi: 10.1007/s10877-015-9794-4. Epub 2015 Oct 13.

  PMID: 26462495 BACKGROUND

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; 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 03Remi). 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 4, 2019
• Study Start: June 9, 2020
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

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)