Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789370
Recruitment Status : Unknown
Verified November 2019 by Chrysanthi Batistaki, Attikon Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Chrysanthi Batistaki, Attikon Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Headache Drug: Propofol Drug: Sevoflurane Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient and the outcomes assessor will not know what kind of anaesthetic drug was used for maintainance of anaesthesia.
Primary Purpose: Prevention
Official Title: Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.
Actual Study Start Date : November 7, 2014
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 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).
 Drug: Propofol
Maintanance of general anaesthesia with propofol
Active Comparator: Sevoflurane
Sevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50).
 Drug: Sevoflurane
Maintainance of general anaesthesia with sevoflurane.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Nausea and vomiting [ Time Frame: up to 24 hours postoperatively ]
    Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789370


Contacts
Layout table for location contacts
Contact: Chrysanthi Batistaki, MD, PhD 00302105832371 chrysabatistaki@yahoo.gr
Contact: Georgia Kostopanagiotou, MD, PhD 00302105832371 banesthclin@attikonhospital.gr

Locations
Layout table for location information
Greece
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str. Recruiting
Athens, Greece, 12462
Contact: Chrysanthi Batistaki, MD, PhD    0030 210 5832371    chrysabatistaki@yahoo.gr   
Sponsors and Collaborators
Attikon Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Chrysanthi Batistaki, Assistant Professor of Anaesthesiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT03789370    
Other Study ID Numbers: 06-11-14
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Headache
Pain
Neurologic Manifestations
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation