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

Primary Purpose

Headache

Status

Unknown status

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Propofol

Sevoflurane

About this trial

This is an interventional prevention trial for Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Propofol

Sevoflurane

Arm 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).

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

Outcomes

Primary Outcome Measures

incidence of postoperative headache (yes or no)

Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)

Secondary Outcome Measures

Nausea and vomiting

Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting

Full Information

NCT ID

NCT03789370

First Posted

January 15, 2018

Last Updated

November 16, 2019

Sponsor

Attikon Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03789370

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 7, 2014 (Actual)

Primary Completion Date

October 30, 2020 (Anticipated)

Study Completion Date

October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Attikon Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Propofol

Arm Type

Active Comparator

Arm Description

Arm Title

Sevoflurane

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

Maintanance of general anaesthesia with propofol

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Intervention Description

Maintainance of general anaesthesia with sevoflurane.

Primary Outcome Measure Information:

Title

incidence of postoperative headache (yes or no)

Description

Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)

Time Frame

up to 24 hours postoperatively

Secondary Outcome Measure Information:

Title

Nausea and vomiting

Description

Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting

Time Frame

up to 24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chrysanthi Batistaki, MD, PhD

Phone

00302105832371

chrysabatistaki@yahoo.gr

First Name & Middle Initial & Last Name or Official Title & Degree

Georgia Kostopanagiotou, MD, PhD

Phone

00302105832371

banesthclin@attikonhospital.gr

Facility Information:

Facility Name

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

City

Athens

ZIP/Postal Code

12462

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chrysanthi Batistaki, MD, PhD

Phone

0030 210 5832371

chrysabatistaki@yahoo.gr

12. IPD Sharing Statement

Learn more about this trial

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

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