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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789370
• Other study ID #: 06-11-14
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2014
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2019
• Source: Attikon Hospital
• Contact: Chrysanthi Batistaki, MD, PhD
• Phone: 00302105832371
• Email: chrysabatistaki[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• Propofol
Maintanance of general anaesthesia with propofol
• Sevoflurane
Maintainance of general anaesthesia with sevoflurane.

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

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