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

Not Applicable

• Conditions: Headache
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT03789370
• Lead Sponsor: Attikon Hospital

Brief 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 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 Timeline

• Study Start: 2014-11-07
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-16
• Last Update Posted: 2019-11-19
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	Sevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50).
Propofol	Propofol	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).

Primary Outcome Measures

Name	Time	Method
incidence of postoperative headache (yes or no)	up to 24 hours postoperatively	Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting	up to 24 hours postoperatively	Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting

Trial Locations

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.; 🇬🇷 Athens, Greece