Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.
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|ClinicalTrials.gov Identifier: NCT03789370|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Headache||Drug: Propofol Drug: Sevoflurane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|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.|
|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|
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).
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).
Maintainance of general anaesthesia with sevoflurane.
- 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)
- Nausea and vomiting [ Time Frame: up to 24 hours postoperatively ]Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting
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
|Contact: Chrysanthi Batistaki, MD, PhDemail@example.com|
|Contact: Georgia Kostopanagiotou, MD, PhDfirstname.lastname@example.org|
|2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.||Recruiting|
|Athens, Greece, 12462|
|Contact: Chrysanthi Batistaki, MD, PhD 0030 210 5832371 email@example.com|