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Clinical Trials/NCT03789370
NCT03789370
Unknown
Not Applicable

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

Attikon Hospital1 site in 1 country130 target enrollmentNovember 7, 2014

Overview

Phase
Not Applicable
Intervention
Sevoflurane
Conditions
Headache
Sponsor
Attikon Hospital
Enrollment
130
Locations
1
Primary Endpoint
incidence of postoperative headache (yes or no)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2014
End Date
October 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Attikon Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chrysanthi Batistaki

Assistant Professor of Anaesthesiology

Attikon Hospital

Eligibility Criteria

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
  • 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

Arms & Interventions

Sevoflurane

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

Intervention: Sevoflurane

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).

Intervention: Propofol

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Nausea and vomiting(up to 24 hours postoperatively)

Study Sites (1)

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