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Hemodynamic InstabilityPhase 4RHNCT03861377

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

A Phase 4 study testing Remifentanil R2, Remifentanil R4 and Remifentanil R8 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 during induction when comparing two low and a medium remifentanil dose and keeping propofol induction dose at about 2.0 mg/kg. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Remifentanil R2, Remifentanil R4 and Remifentanil R8
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteNorway
Study dates
9 Jun 2020to 2 Feb 2022
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

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

Who cannot join

  • 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.
Show all 12Show fewer
  • Kidney or hepatic disease
  • Hypersensitivity for propofol, soya, eggs or peanuts
  • Pregnancy
  • Poor health state
  • Illicit substance use
  • BMI <20 or >35 kg/m2

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Kirurgisk Klinikk Anestesi

    Haugesund, Rogaland, 5504

Other trials in Norway

About this study

Official title: "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.

Read the 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.

Being tested
Remifentanil R2, Remifentanil R4, Remifentanil R8
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

What participants receive

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

  • Remifentanil R2Drug

    Also called Ultiva

    0,7 microg/kg

  • Remifentanil R4Drug

    Also called Ultiva

    1,1 microg/kg

  • Remifentanil R8Drug

    Also called Ultiva

    1,7 microg/kg

Study groups in NCT03861377
Study groupRoleWhat they receive
Remifentanil R2Active comparatorLow dose Remifentanil induction dose (R2)
Receives: Drug: Remifentanil R2
Remifentanil R4Active comparatorMedium dose Remifentanil induction dose (R4)
Receives: Drug: Remifentanil R4
Remifentanil R8Active comparatorMedium dose Remifentanil induction dose (R8)
Receives: Drug: Remifentanil R8

What is being measured

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

  1. Systolic Blood Pressure (SBP)

    Change in systolic blood pressure during induction

    Measured: First 7,5 minutes from start of induction

  2. Heart Rate (HR)

    Change in heart rate during induction

    Measured: First 7,5 minutes from start of induction

Secondary outcomes (3)

  1. Stroke Volume (SV)

    Change in stroke volume during induction

    Measured: First 7,5 minutes from start of induction

  2. Cardiac Output (CO)

    Change in cardiac output during induction

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

  3. Systemic Vascular Resistance (SVR)

    Change in systemic vascular resistance during induction

    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 posted4 Mar 2019
  2. Study start9 Jun 2020
  3. Primary completion2 Feb 2022
  4. Study completion2 Feb 2022

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
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03861377
Sponsor's protocol ID
2019/376
Other IDs
2019-000961-19, 2019
Acronym
RH
Status last verified
Mar 2022
First submitted
1 Mar 2019
Last updated
21 Mar 2022
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

  • 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

  • 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

  • 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.

    PubMed 12790210

  • 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.

    PubMed 19457895

  • 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.

    PubMed 26462495

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Remifentanil R2, Remifentanil R4 and Remifentanil R8 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 12 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 21 Mar 2022. 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. 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 NCT03861377, which also lists 5 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 21 Mar 2022.

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