Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
190 participants
INTERVENTIONAL
2018-01-01
2022-12-07
Brief Summary
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Detailed Description
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This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Dimenydrinate
Preoperative per os administration of 50 mg dimenydrinate
Dimenhydrinate Tablets
2 hours preoperative per os administration of 50 mg dimenhydrinate
Ondasentron
Intraoperative intravenous administration of 4 mg ondansetron
Ondansetron iv
Intraoperative intravenous administration of 4 mg ondansetron
Interventions
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Dimenhydrinate Tablets
2 hours preoperative per os administration of 50 mg dimenhydrinate
Ondansetron iv
Intraoperative intravenous administration of 4 mg ondansetron
Eligibility Criteria
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Inclusion Criteria
* ASA PS I-III
* Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations
Exclusion Criteria
* Age other than 18-75 years old
* Pregnant patients
* Non-elective operations
* Patients that are not able to receive p.os agents
* Medical history of Brugada Sdr or Brugada-like/related ECG abnormalities
* Long-Qt Sdr or concurrent use of medications that may cause long-QT ECG abnormalities
* Medical or family history of psychosis
* Allergy in dimenydrinate or in dimenydrinate drug versions
* Perioperative use of dexamethasone
18 Years
75 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Elena Arnaoutoglou
Professor of anesthesiology
Principal Investigators
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Elena Arnaoutoglou, MD, PhD
Role: STUDY_CHAIR
University of Thessaly
Konstantinos George Stamoulis, MD, PhD
Role: STUDY_DIRECTOR
University Hospital of Larissa
Locations
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University Hospital of Larisa, Department of Anesthesiology
Larissa, Thessaly, Greece
Countries
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Other Identifiers
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52699
Identifier Type: -
Identifier Source: org_study_id
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