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Hemodynamic InstabilityPhase 4VHNCT03864094

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

A Phase 4 study testing Ephedrine, Phenylephrine and Norepinephrine in people with Hemodynamic Instability and Anesthesia, General, run by Helse Fonna at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Ephedrine, Phenylephrine and Norepinephrine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteNorway
Study dates
15 Mar 2022to 14 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Pre-existing hypertension
  • Diabetes for several years
  • Ischemic heart disease
  • Cerebrovascular disease
  • Heart valve disease
  • Verified cardiac arrhythmia
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Helse Fonna, Haugesund Sykehus

    Haugesund

Other trials in Norway

About this study

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."

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.

Read the 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.

Being tested
Ephedrine, Phenylephrine, Norepinephrine, Sodium chloride, Propofol
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EphedrineDrug

    Also called Ephedrine Sulphate Injection

    0,1 mg/kg

  • PhenylephrineDrug

    Also called Phenylephrine Hydrocloride Injection

    1 microg/kg

  • NorepinephrineDrug

    Also called Noradrenalin

    0,1 microg/kg

  • Sodium chlorideDrug

    Also called Sodium Chloride 0,9% injection

    0,1 ml/kg

  • PropofolDrug

    Also called Propolipid

    2 mg/kg

  • RemifentanilDrug

    Also called Ultiva

    1,7 microg/kg

Study groups in NCT03864094
Study groupRoleWhat they receive
Ephedrine Propofol RemifentanilActive comparatorProphylactic Ephedrine
Receives: Drug: Ephedrine; Drug: Propofol; Drug: Remifentanil
Phenylephrine Propofol RemifentanilActive comparatorProphylactic Phenylephrine
Receives: Drug: Phenylephrine; Drug: Propofol; Drug: Remifentanil
Norepinephrine Propofol RemifentanilActive comparatorProphylactic Norepinephrine
Receives: Drug: Norepinephrine; Drug: Propofol; Drug: Remifentanil
Sodium chloride Propofol RemifentanilSham comparatorNaCl Placebo
Receives: Drug: Sodium chloride; Drug: Propofol; Drug: Remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic Blood Pressure (SBP)

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

    Measured: First 7,5 minutes from start of induction

  2. Heart Rate (HR)

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

    Measured: First 7,5 minutes from start of induction

Secondary outcomes (3)

  1. Stroke Volume (SV)

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

    Measured: First 7,5 minutes from start of induction

  2. Cardiac Output (CO)

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

    Measured: First 7,5 minutes from a start of induction

  3. Systemic Vascular Resistance (SVR)

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

    Measured: First 7,5 minutes from start of induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2019
  2. Study start15 Mar 2022
  3. Primary completion14 Dec 2023
  4. Study completion14 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, controlled, double-blind.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03864094
Sponsor's protocol ID
2019/374
Other IDs
2019-000965-19, 2019
Acronym
VH
Status last verified
Oct 2024
First submitted
1 Mar 2019
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 1751277

  • 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.

    PubMed 10844832

  • 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.

    PubMed 9771299

  • 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.

    PubMed 15449752

  • 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.

    PubMed 21196672

  • 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.

    PubMed 24803761

  • 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.

    PubMed 41144827

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ephedrine, Phenylephrine and Norepinephrine in people with Hemodynamic Instability and Anesthesia, General, run by Helse Fonna at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (SBP) (time frame: First 7,5 minutes from start of induction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03864094, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

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