Hemodynamics InstabilityPhase 4PHNCT03861364
Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
A Phase 4 study testing Propofol in people with Hemodynamics Instability and Anesthesia, General, run by Helse Fonna at 1 site in Norway.
Trial summary
The study objective is to examine if a high propofol dose is non-inferior to a low dose in respect to hemodynamic stability in healthy patients during induction of general anesthesia with propofol and remifentanil. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hemodynamics Instability, Anesthesia, General, Anesthesia, Intravenous
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNorway
- Study dates
- 3 Sep 2019to 31 May 2020
- 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.
About this study
Official title: Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.
The study objective is to examine if a high propofol dose is non-inferior to a low dose in respect to hemodynamic stability in healthy patients during induction of general anesthesia with propofol and remifentanil.
Read the detailed description
Typically, one or more adjuvant medications are administered to supplement induction of general anesthesia. When combining anesthetic drugs, 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.
Claeys (1988) and Fairfield (1991) examined the cardiovascular effects of propofol 2-2.5 mg/kg induction dose and found significant reductions i SBP and SVR and small changes in CO, SV and HR. De Wit (2016) examined hemodynamic changes in different steady state propofol serum concentrations, and found a dose dependent SBP reduction, reduction in resistance of arterial and systemic circulation and a reduction in mean systemic filling pressures (MSFP) indicative of a reduction in "stressed volumes". The effective dose (ED) 95% for loss of consciousness for propofol was determined to 1.75 mg/kg when used alone, and 1.38 mg/kg when used together with remifentanil 0.25 microg/kg/min (total induction dose 1.75 microg/kg remifentanil) in a study by Koh et al. We want to examine the hemodynamic effects of giving a low (1.4 mg/kg) vs a high (2.4 mg/kg) propofol dose combined with a moderate remifentanil dose (about 1.5 microg/kg).
- Being tested
- 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, Propolipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Propofol | Active comparator | High Propofol induction dose Receives: Drug: Propofol |
| Low Propofol | Active comparator | Low Propofol induction dose Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (SBP)
Relative change of SBP (mmHg)
Measured: The first 7.5 minutes during induction of general anesthesia
Heart rate (HR)
Relative change of HR (beats)
Measured: The first 7.5 minutes during induction of general anesthesia
Secondary outcomes (3)
Stroke Volume (SV)
Relative change of SV (ml/beat)
Measured: The first 7.5 minutes during induction of general anesthesia
Cardiac Output (CO)
Relative change of CO (litre/min)
Measured: The first 7.5 minutes during induction of general anesthesia
Systemic Vascular Resistance (SVR)
Relative change of SVR (dynes-sec/cm5/m2)
Measured: The first 7.5 minutes during induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start3 Sep 2019
- Primary completion19 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hemodynamics InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Helge Sjøen, Helse Fonna
- Investigators
- Gunnar H Sjøen, MD, Principal investigator, Helse Fonna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861364
- Sponsor's protocol ID
- 2019/375
- Other IDs
- 2019-000958-56, 2019
- Acronym
- PH
- Status last verified
- Jun 2020
- First submitted
- 1 Mar 2019
- Last updated
- 17 Jun 2020
- 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
Koh JC, Park J, Kim NY, You AH, Ko SH, Han DW. Effects of remifentanil with or without midazolam pretreatment on the 95% effective dose of propofol for loss of consciousness during induction: A randomized, clinical trial. Medicine (Baltimore). 2017 Dec;96(49):e9164. doi: 10.1097/MD.0000000000009164.
PubMed 29245361Claeys MA, Gepts E, Camu F. Haemodynamic changes during anaesthesia induced and maintained with propofol. Br J Anaesth. 1988 Jan;60(1):3-9. doi: 10.1093/bja/60.1.3.
PubMed 3257393Fairfield 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 1751277de Wit F, van Vliet AL, de Wilde RB, Jansen JR, Vuyk J, Aarts LP, de Jonge E, Veelo DP, Geerts BF. The effect of propofol on haemodynamics: cardiac output, venous return, mean systemic filling pressure, and vascular resistances. Br J Anaesth. 2016 Jun;116(6):784-9. doi: 10.1093/bja/aew126.
PubMed 27199311Sjoen GH, Falk RS, Hauge TH, Tonnessen TI, Langesaeter E. Hemodynamic effects of a low versus a high dose of propofol during induction of anesthesia. A randomized trial. Acta Anaesthesiol Scand. 2023 Oct;67(9):1178-1186. doi: 10.1111/aas.14293. Epub 2023 Jun 8.
PubMed 37291731
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.
- ClinicalTrials.gov ID
- NCT03861364
- Acronym / sponsor ID
- PH / 2019/375
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to examine if a high propofol dose is non-inferior to a low dose in respect to hemodynamic stability in healthy patients during induction of general anesthesia with propofol and remifentanil.
Detailed description
Typically, one or more adjuvant medications are administered to supplement induction of general anesthesia. When combining anesthetic drugs, 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.
Claeys (1988) and Fairfield (1991) examined the cardiovascular effects of propofol 2-2.5 mg/kg induction dose and found significant reductions i SBP and SVR and small changes in CO, SV and HR. De Wit (2016) examined hemodynamic changes in different steady state propofol serum concentrations, and found a dose dependent SBP reduction, reduction in resistance of arterial and systemic circulation and a reduction in mean systemic filling pressures (MSFP) indicative of a reduction in "stressed volumes". The effective dose (ED) 95% for loss of consciousness for propofol was determined to 1.75 mg/kg when used alone, and 1.38 mg/kg when used together with remifentanil 0.25 microg/kg/min (total induction dose 1.75 microg/kg remifentanil) in a study by Koh et al. We want to examine the hemodynamic effects of giving a low (1.4 mg/kg) vs a high (2.4 mg/kg) propofol dose combined with a moderate remifentanil dose (about 1.5 microg/kg).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double blind.
| Arm | Type | Receives |
|---|---|---|
| High Propofol | Active comparator | Drug: PropofolHigh Propofol induction dose |
| Low Propofol | Active comparator | Drug: PropofolLow Propofol induction dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy women
- Age 18-50 years
- Gynecological procedures
- General anesthesia
Key exclusion criteria (15 listed)
- Pre-existing hypertension
- Diabetes for several years
- Ischemic heart disease
- Cerebrovascular disease
- Heart valve disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Propolipid2,4 mg/kg | Drug | High Propofol |
| PropofolAlso: Propolipid1,4 mg/kg | Drug | Low Propofol |
Primary outcome
Systolic blood pressure (SBP)
Time frame: The first 7.5 minutes during induction of general anesthesia
Relative change of SBP (mmHg)
Heart rate (HR)
Time frame: The first 7.5 minutes during induction of general anesthesia
Relative change of HR (beats)
3 secondary outcomes
Stroke Volume (SV)
Time frame: The first 7.5 minutes during induction of general anesthesia
Cardiac Output (CO)
Time frame: The first 7.5 minutes during induction of general anesthesia
Systemic Vascular Resistance (SVR)
Time frame: The first 7.5 minutes during induction of general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Background: PubMed 29245361Koh JC, Park J, Kim NY, You AH, Ko SH, Han DW. Effects of remifentanil with or without midazolam pretreatment on the 95% effective dose of propofol for loss of consciousness during induction: A randomized, clinical trial. Medicine (Baltimore). 2017 Dec;96(49):e9164. doi: 10.1097/MD.0000000000009164.
- Background: PubMed 3257393Claeys MA, Gepts E, Camu F. Haemodynamic changes during anaesthesia induced and maintained with propofol. Br J Anaesth. 1988 Jan;60(1):3-9. doi: 10.1093/bja/60.1.3.
- Background: PubMed 1751277Fairfield 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.
- Background: PubMed 27199311de Wit F, van Vliet AL, de Wilde RB, Jansen JR, Vuyk J, Aarts LP, de Jonge E, Veelo DP, Geerts BF. The effect of propofol on haemodynamics: cardiac output, venous return, mean systemic filling pressure, and vascular resistances. Br J Anaesth. 2016 Jun;116(6):784-9. doi: 10.1093/bja/aew126.
- Derived from this study: PubMed 37291731Sjoen GH, Falk RS, Hauge TH, Tonnessen TI, Langesaeter E. Hemodynamic effects of a low versus a high dose of propofol during induction of anesthesia. A randomized trial. Acta Anaesthesiol Scand. 2023 Oct;67(9):1178-1186. doi: 10.1111/aas.14293. Epub 2023 Jun 8.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar H Sjøen, MD principal investigator
Helse Fonna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol in people with Hemodynamics 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 17 Jun 2020. 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: The first 7.5 minutes during induction of general anesthesia). 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 NCT03861364, 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 17 Jun 2020.