Dimenydrinate vs Ondansetron for PONV (DONV)
- Conditions
- PONV in Laparoscopic Cholocystectomies
- Interventions
- Registration Number
- NCT05590936
- Lead Sponsor
- University of Thessaly
- Brief Summary
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.
- Detailed Description
Dimenydrinate has been extensively used for motion sickness. However, as far as postoperative nausea and vomiting is concerned the results are still conflicting.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- Age 18-75 years old
- ASA PS I-III
- Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations
- Refused to participate
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dimenydrinate Dimenhydrinate Tablets Preoperative per os administration of 50 mg dimenydrinate Ondasentron Ondansetron iv Intraoperative intravenous administration of 4 mg ondansetron
- Primary Outcome Measures
Name Time Method PONV 24 hours postoperative PONV recording in patients undergone laparoscopic cholocystectomy
- Secondary Outcome Measures
Name Time Method Awaken time on extubation time from anesthetic drug cessation until extubation
preoperative anxiety 30 minutes before operation preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale
Trial Locations
- Locations (1)
University Hospital of Larisa, Department of Anesthesiology
🇬🇷Larissa, Thessaly, Greece