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

March 18, 2022 updated by: Gunnar Helge Sjøen, Helse Fonna

"Hemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Medium and Low Remifentanil Doses."

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Typically, one or more adjuvant medications is administered during induction of general anesthesia. When anesthetic drugs are combined, the hypnotic effects are often synergistic. Propofol is associated with hypotension and bradycardia and used together with remifentanil or sedative agents it may give synergistic or additive sedative and hemodynamic effects.

Remifentanil is infused at 0.05-0.3 microg/kg/min during induction of anesthesia. Some use a loading dose of 0.5-1.0 microg/kg before starting the continuous infusion. The onset of action of remifentanil is within one to two minutes and it reaches rapidly a steady state effect site concentration after a bolus dose.

Kazmaier (2000) showed that a high-dose remifentanil anesthesia (2 microg/kg/min) reduced cardiac index (-25%), stroke volume (-14%) and mean arterial blood pressure (-39%) in a similar manner as propofol/remifentanil (propofol target 2 microg/ml and remifentanil 0.5 microg/kg/min), but systemic vascular resistance index decreased (-14%) in propofol/remifentanil combination. Fairfield et al have earlier (1991) showed that propofol 2.5 mg/kg induction without opioid reduces cardiac output (-15%) stroke volume (-5 %), mean arterial pressure (-33%) and systemic vascular resistance (-11%) and a slight reduction i heart rate. Guarracino (2003) suggests the reduction in cardiac index during induction with propofol/remifentanil with a low propofol target (1.2 microg/ml) may be due to decreased heart rate. Zaballos (2009) have shown that remifentanil depresses sinus node and atrioventricular (AV) -nodal function in comparison with propofol alone in a closed chest porcine model. Hayashi (2016) states that even in a low remifentanil effect site concentration (3.5 nanog/ml) it may reduce heart rate significantly when combined with propofol bolus 30-50 mg.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Rogaland
      • Haugesund, Rogaland, Norway, 5504
        • Kirurgisk Klinikk Anestesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remifentanil R2
Low dose Remifentanil induction dose (R2)
Drug: Remifentanil R2
0,7 microg/kg
Other Names:
  • Ultiva
Active Comparator: Remifentanil R4
Medium dose Remifentanil induction dose (R4)
Drug: Remifentanil R4
1,1 microg/kg
Other Names:
  • Ultiva
Active Comparator: Remifentanil R8
Medium dose Remifentanil induction dose (R8)
Drug: Remifentanil R8
1,7 microg/kg
Other Names:
  • Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure (SBP)
Time Frame: First 7,5 minutes from start of induction
Change in systolic blood pressure during induction
First 7,5 minutes from start of induction
Heart Rate (HR)
Time Frame: First 7,5 minutes from start of induction
Change in heart rate during induction
First 7,5 minutes from start of induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Volume (SV)
Time Frame: First 7,5 minutes from start of induction
Change in stroke volume during induction
First 7,5 minutes from start of induction
Cardiac Output (CO)
Time Frame: First 7,5 minutes from a start of induction
Change in cardiac output during induction
First 7,5 minutes from a start of induction
Systemic Vascular Resistance (SVR)
Time Frame: First 7,5 minutes from start of induction
Change in systemic vascular resistance during induction
First 7,5 minutes from start of induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Fonna

Investigators

  • Principal Investigator: Gunnar Sjøen, MD, Helse Fonna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2020

Primary Completion (Actual)

February 2, 2022

Study Completion (Actual)

February 2, 2022

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/376
  • 2019-000961-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

LiDCO-csv raw data and processed data will be made public at the publishers site, and the supporting information by request to the Principal Investigator. Statistical Data Plan is included in Study Protocol.

IPD Sharing Time Frame

The data will be stored for 15 years after end of study, and may be shared during this time frame.

IPD Sharing Access Criteria

The data may be shared by contacting the Principal Investigator.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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