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

September 26, 2023 updated by: Gunnar Helge Sjøen, Helse Fonna

"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."

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The LiDCOplus monitoring system (Lithium Dilutional Cardiac Output (LiDCO) Ltd., Cambridge, United Kingdom) is a minimally invasive monitor for measuring stroke volume (SV) using two different algorithms. The PulseCO (PulseCO ™, Cambridge, United Kingdom) is based on analyses of the the arterial pressure wave giving nominal values. The LiDCO uses lithium-dilution for calibration to give absolute values. In this trial, the investigators will use the PulseCO looking at relative changes in uncalibrated hemodynamic variables. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured.

Earlier studies have shown that propofol 2.5 mg/kg induction without opioid reduces CO (-15%), SV (-5 %), MAP (-33%) and SVR (-11%) and a slight reduction i HR. High-dose remifentanil anesthesia (2 microg/kg/min), in coronary patients reduced cardiac index (-25%), SV (-14%) and MAP (-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.

Several procedures have been proposed to minimize the negative hemodynamic changes during induction. Administration of a crystalloid or a colloid did not prevent the decrease in MAP after induction of general anesthesia with propofol and fentanyl.

The hemodynamic effects in propofol-fentanyl anesthesia of preoperative ephedrine 0.07-0.15 mg/kg vs phenylephrine 1.5 microg/kg in valve surgery and concludes that ephedrine 0.07-0.1 mg/kg is safe and effective in counteracting hypotension. A dose of 0.15 mg/kg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 2.5 mg/kg and remifentanil 3 microg/kg.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

Study Locations

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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Description

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

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: Ephedrine Propofol Remifentanil
Prophylactic Ephedrine
Drug: Ephedrine
0,1 mg/kg
Other Names:
  • Ephedrine Sulphate Injection
Drug: Propofol
2 mg/kg
Other Names:
  • Propolipid
Drug: Remifentanil
1,7 microg/kg
Other Names:
  • Ultiva
Active Comparator: Phenylephrine Propofol Remifentanil
Prophylactic Phenylephrine
Drug: Propofol
2 mg/kg
Other Names:
  • Propolipid
Drug: Remifentanil
1,7 microg/kg
Other Names:
  • Ultiva
Drug: Phenylephrine
1 microg/kg
Other Names:
  • Phenylephrine Hydrocloride Injection
Active Comparator: Norepinephrine Propofol Remifentanil
Prophylactic Norepinephrine
Drug: Propofol
2 mg/kg
Other Names:
  • Propolipid
Drug: Remifentanil
1,7 microg/kg
Other Names:
  • Ultiva
Drug: Norepinephrine
0,1 microg/kg
Other Names:
  • Noradrenalin
Sham Comparator: Sodium chloride Propofol Remifentanil
NaCl Placebo
Drug: Propofol
2 mg/kg
Other Names:
  • Propolipid
Drug: Remifentanil
1,7 microg/kg
Other Names:
  • Ultiva
Drug: Sodium chloride
0,1 ml/kg
Other Names:
  • Sodium Chloride 0,9% injection

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 SBP during induction as measured by the LiDCOplus monitoring system
First 7,5 minutes from start of induction
Heart Rate (HR)
Time Frame: First 7,5 minutes from start of induction
Change in HR during induction as measured by the LiDCOplus monitoring system
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 SV during induction as measured by the LiDCOplus monitoring system
First 7,5 minutes from start of induction
Cardiac Output (CO)
Time Frame: First 7,5 minutes from a start of induction
Change in CO during induction as measured by the LiDCOplus monitoring system
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 SVR during induction as measured by the LiDCOplus monitoring system
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)

March 15, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 2, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/374
  • 2019-000965-19 (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
  • ICF
  • 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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