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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864094
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Gunnar Helge Sjøen, Helse Fonna

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.

Condition or disease Intervention/treatment Phase
Hemodynamic Instability Anesthesia, General Anesthesia, Intravenous Drug: Ephedrine Drug: Phenylephrine Drug: Norepinephrine Drug: Sodium chloride Drug: Propofol Drug: Remifentanil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, double-blind.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: "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."
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


Arm Intervention/treatment
Active Comparator: Ephedrine Propofol Remifentanil
Prophylactic Ephedrine
Drug: Ephedrine
0,1 mg/kg
Other Name: Ephedrine Sulphate Injection

Drug: Propofol
2 mg/kg
Other Name: Propolipid

Drug: Remifentanil
1,7 microg/kg
Other Name: Ultiva

Active Comparator: Phenylephrine Propofol Remifentanil
Prophylactic Phenylephrine
Drug: Phenylephrine
1 microg/kg
Other Name: Phenylephrine Hydrocloride Injection

Drug: Propofol
2 mg/kg
Other Name: Propolipid

Drug: Remifentanil
1,7 microg/kg
Other Name: Ultiva

Active Comparator: Norepinephrine Propofol Remifentanil
Prophylactic Norepinephrine
Drug: Norepinephrine
0,1 microg/kg
Other Name: Noradrenalin

Drug: Propofol
2 mg/kg
Other Name: Propolipid

Drug: Remifentanil
1,7 microg/kg
Other Name: Ultiva

Sham Comparator: Sodium chloride Propofol Remifentanil
NaCl Placebo
Drug: Sodium chloride
0,1 ml/kg
Other Name: Sodium Chloride 0,9% injection

Drug: Propofol
2 mg/kg
Other Name: Propolipid

Drug: Remifentanil
1,7 microg/kg
Other Name: Ultiva




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864094


Contacts
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Contact: Haldis Økland Lier 004752732000 haldis.johanne.okland.lier@helse-fonna.no
Contact: Olav Klausen 52732020 ext 0047 olav.godtfred.klausen@helse-fonna.no

Locations
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Norway
Helse Fonna, Haugesund Sykehus Recruiting
Haugesund, Norway
Contact: Gunnar Sjøen    52732000 ext 0047    gunnar.helge.sjoeen@helse-fonna.no   
Contact: Haldis Lier    52732000 ext 0047    haldis.johanne.okland.lier@helse-fonna.no   
Sponsors and Collaborators
Helse Fonna
Investigators
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Principal Investigator: Gunnar Sjøen, MD Helse Fonna
Publications:
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Responsible Party: Gunnar Helge Sjøen, Consultant in Anesthesiology, Helse Fonna
ClinicalTrials.gov Identifier: NCT03864094    
Other Study ID Numbers: 2019/374
2019-000965-19 ( EudraCT Number )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gunnar Helge Sjøen, Helse Fonna:
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
Additional relevant MeSH terms:
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Phenylephrine
Oxymetazoline
Norepinephrine
Ephedrine
Pseudoephedrine
Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents