NCT03789370

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

6 years

First QC Date

January 15, 2018

Last Update Submit

November 16, 2019

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Nausea and vomiting

    up to 24 hours postoperatively

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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).

Drug: Propofol

Sevoflurane

ACTIVE COMPARATOR

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

Drug: Sevoflurane

Interventions

PropofolDRUG

Maintanance of general anaesthesia with propofol

Propofol
SevofluraneDRUG

Maintainance of general anaesthesia with sevoflurane.

Sevoflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Headache

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Central Study Contacts

Chrysanthi Batistaki, MD, PhD

CONTACT

00302105832371chrysabatistaki@yahoo.gr

Georgia Kostopanagiotou, MD, PhD

CONTACT

00302105832371banesthclin@attikonhospital.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the outcomes assessor will not know what kind of anaesthetic drug was used for maintainance of anaesthesia.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anaesthesiology

Study Record Dates

First Submitted

January 15, 2018

First Posted

December 28, 2018

Study Start

November 7, 2014

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

GR(1)