General AnesthesiaNCT03098875
Heart Rate Variability Under Propofol and Sevoflurane
A study testing Sevoflurane, Propofol and Remifentanil in people with General Anesthesia, run by Hôpital Armand Trousseau at 1 site in France.
Trial summary
Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Sevoflurane, Propofol and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Sep 2010
- Phase
- Interventional
- 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 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA risk classification 1 or 2,
- scheduled for middle ear surgery, or cardiovascular ANS activity.
Who cannot join
- preoperative medications that interfere with the autonomic nervous system
- preoperative medications that interfere with the central nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane
Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability
- Conditions
- General Anesthesia
- Being tested
- Sevoflurane, Propofol, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
General anesthesia using sevoflurane as a hypnotic agent
PropofolDrug
General anesthesia using propofol as a hypnotic agent
RemifentanilDrug
General anesthesia using remifentanil as an analgesic.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | General anesthesia using sevoflurane as a hypnotic agent, and remifentanil as an analgesic.
Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability. Receives: Drug: Sevoflurane; Drug: Remifentanil |
| Propofol | Active comparator | General anesthesia using propofol as a hypnotic agent, and remifentanil as an analgesic.
Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability. Receives: Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral analysis of heart rate variability with a bispectral index of 25
Fast Fourier Transform applied to heart rate signal recording
Measured: During surgical procedure
Spectral analysis of heart rate variability with a bispectral index of 55
Fast Fourier Transform applied to heart rate signal recording
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startJan 2009
- Primary completionDec 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098875
- Sponsor's protocol ID
- HRV Propofol Sevoflurane
- Status last verified
- Mar 2017
- First submitted
- 9 Jan 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane
- ClinicalTrials.gov ID
- NCT03098875
- Acronym / sponsor ID
- HRV Propofol Sevoflurane
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Apr 2017 (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.
Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: Sevoflurane, Drug: RemifentanilGeneral anesthesia using sevoflurane as a hypnotic agent, and remifentanil as an analgesic. Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability. |
| Propofol | Active comparator | Drug: Propofol, Drug: RemifentanilGeneral anesthesia using propofol as a hypnotic agent, and remifentanil as an analgesic. Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ASA risk classification 1 or 2,
- scheduled for middle ear surgery, or cardiovascular ANS activity.
Key exclusion criteria (2 listed)
- preoperative medications that interfere with the autonomic nervous system
- preoperative medications that interfere with the central nervous system
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 |
|---|---|---|
| SevofluraneGeneral anesthesia using sevoflurane as a hypnotic agent | Drug | Sevoflurane |
| PropofolGeneral anesthesia using propofol as a hypnotic agent | Drug | Propofol |
| RemifentanilGeneral anesthesia using remifentanil as an analgesic. | Drug | Propofol, Sevoflurane |
Primary outcome
Spectral analysis of heart rate variability with a bispectral index of 25
Time frame: During surgical procedure
Fast Fourier Transform applied to heart rate signal recording
Spectral analysis of heart rate variability with a bispectral index of 55
Time frame: During surgical procedure
Fast Fourier Transform applied to heart rate signal recording
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 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane, Propofol and Remifentanil in people with General Anesthesia, run by Hôpital Armand Trousseau at 1 site in France.
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 2 inclusion and 2 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 Apr 2017. 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 France. 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.
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?
Spectral analysis of heart rate variability with a bispectral index of 25 (time frame: During surgical procedure). 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?
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 Apr 2017.