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

Attikon University Hospital

Status: Unknown

Conditions: Headache

Treatments: Drug: Propofol; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT03789370

06-11-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Propofol

Active Comparator group

Description:

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).

Treatment:

Drug: Propofol

Sevoflurane

Active Comparator group

Description:

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

Treatment:

Drug: Sevoflurane