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Dimenydrinate vs Ondansetron for PONV (DONV)

Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05590936
Acronym
DONV
Enrollment
190
Registered
2022-10-21
Start date
2018-01-01
Completion date
2022-12-07
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PONV in Laparoscopic Cholocystectomies

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.

Interventions

DRUGDimenhydrinate Tablets

2 hours preoperative per os administration of 50 mg dimenhydrinate

Intraoperative intravenous administration of 4 mg ondansetron

Sponsors

University of Thessaly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-75 years old * ASA PS I-III * Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
PONV30 minutes postoperativePONV recording in patients undergone laparoscopic cholocystectomy

Secondary

MeasureTime frameDescription
preoperative anxiety24 hours before operationpreoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale
Awaken timeon extubationtime from anesthetic drug cessation until extubation

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026