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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03789370

Enrollment

130

Registered

2018-12-28

Start date

2014-11-07

Completion date

2020-10-30

Last updated

2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache

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.

Interventions

DRUGPropofol

Maintanance of general anaesthesia with propofol

DRUGSevoflurane

Maintainance of general anaesthesia with sevoflurane.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient and the outcomes assessor will not know what kind of anaesthetic drug was used for maintainance of anaesthesia.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Greece

Contacts

Primary ContactChrysanthi Batistaki, MD, PhD

chrysabatistaki@yahoo.gr00302105832371

Backup ContactGeorgia Kostopanagiotou, MD, PhD

banesthclin@attikonhospital.gr00302105832371

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026