HeadacheNCT03789370
Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.
A study testing Propofol and Sevoflurane in people with Headache, run by Attikon Hospital at 1 site in Greece.
Trial summary
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, which is supposed to have protective effects on migraine patients, versus… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGreece
- Study dates
- 7 Nov 2014to 30 Oct 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- scheduled operation under general anaesthesia
- operations <4 hours
- minorgynaecological operatios (leiomyomectomy)
- hernia repair
- arthroscopic procedurs
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- minor orthopaedic operations without the use of tourniquet or cement
- saphenectomy
- minor urologic operations
- minor other operations of general surgery
Who cannot join
- age <18 and >65 years old
- ASA>III
- Diseases of the central nervous system (ie Parkinsons's disease, Multiple sclerosis, previous ischaemic attack, hydrocephalus, seizure disorder, etc)
- Psychosis under medication
- Cognitive impairement or/and inability to fill in the questionaires
- Allergy or contraindication to the study protocol included drugs
Show all 11Show fewer
- Operations of more than 4 hours duration
- Head and neck procedures, procedures with neck extension (eg thyroidectomy), ENT procedures
- renal impairement
- hepatic impairement
- patient refusal
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462
Chrysanthi Batistaki, MD, PhD, 0030 210 5832371, chrysabatistaki@yahoo.gr
About this study
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, which is supposed to have protective effects on migraine patients, versus sevoflurane.
Read the detailed description
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, versus sevoflurane. Propofol acts throught a GABA, and is known to have a therapeutic effect on migraine patients with accute attacts. However, its role on postoperative headache has not been studied, when used for maintainance of anaesthesia, this study aims to investigate the occurrence of headache after anaesthesia and surgery, when patients receive randomly two different anaesthetics: propofol and sevoflurane.
- Conditions
- Headache
- Being tested
- Propofol, Sevoflurane
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Maintanance of general anaesthesia with propofol
SevofluraneDrug
Maintainance of general anaesthesia with sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Total intravenous anaesthesia with propofol for maintainance of anaesthesia.Dose adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). Initial dose 10 mg/kg/h for10 min, 8 mg/kg/h for 10 min and then 6 mg/kg/h). Receives: Drug: Propofol |
| Sevoflurane | Active comparator | Sevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative headache (yes or no)
Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)
Measured: up to 24 hours postoperatively
Secondary outcomes (1)
Nausea and vomiting
Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting
Measured: up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start7 Nov 2014
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysanthi Batistaki, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789370
- Sponsor's protocol ID
- 06-11-14
- Status last verified
- Nov 2019
- First submitted
- 15 Jan 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.
- ClinicalTrials.gov ID
- NCT03789370
- Acronym / sponsor ID
- 06-11-14
- Conditions
- Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 28 Dec 2018 (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.
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, which is supposed to have protective effects on migraine patients, versus sevoflurane.
Detailed description
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, versus sevoflurane. Propofol acts throught a GABA, and is known to have a therapeutic effect on migraine patients with accute attacts. However, its role on postoperative headache has not been studied, when used for maintainance of anaesthesia, this study aims to investigate the occurrence of headache after anaesthesia and surgery, when patients receive randomly two different anaesthetics: propofol and sevoflurane.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolTotal intravenous anaesthesia with propofol for maintainance of anaesthesia.Dose adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). Initial dose 10 mg/kg/h for10 min, 8 mg/kg/h for 10 min and then 6 mg/kg/h). |
| Sevoflurane | Active comparator | Drug: SevofluraneSevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ASA I-III
- scheduled operation under general anaesthesia
- operations <4 hours
- minorgynaecological operatios (leiomyomectomy)
- hernia repair
Key exclusion criteria (11 listed)
- age <18 and >65 years old
- ASA>III
- Diseases of the central nervous system (ie Parkinsons's disease, Multiple sclerosis, previous ischaemic attack, hydrocephalus, seizure disorder, etc)
- Psychosis under medication
- Cognitive impairement or/and inability to fill in the questionaires
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 |
|---|---|---|
| PropofolMaintanance of general anaesthesia with propofol | Drug | Propofol |
| SevofluraneMaintainance of general anaesthesia with sevoflurane. | Drug | Sevoflurane |
Primary outcome
incidence of postoperative headache (yes or no)
Time frame: up to 24 hours postoperatively
Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)
1 secondary outcome
Nausea and vomiting
Time frame: up to 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Headache, run by Attikon Hospital at 1 site in Greece.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Nov 2019. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chrysanthi Batistaki, MD, PhD (00302105832371, chrysabatistaki@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative headache (yes or no) (time frame: up to 24 hours postoperatively). 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 19 Nov 2019.