Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.

Conditions
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Headache

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III scheduled operation under general anaesthesia operations <4 hours minorgynaecological operatios (leiomyomectomy) hernia repair arthroscopic procedurs minor orthopaedic operations without the use of tourniquet or cement saphenectomy minor urologic operations minor other operations of general surgery Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>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). | Drug: Propofol<br>* Maintanance of general anaesthesia with propofol<br>|
| Active Comparator: Sevoflurane<br>Sevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). | Drug: Sevoflurane<br>* Maintainance of general anaesthesia with sevoflurane.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative headache (yes or no) | Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache) | up to 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting | Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting | up to 24 hours postoperatively |