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Dimenydrinate vs Ondansetron for PONV (DONV)

Sponsor
University of Thessaly (Other)
Overall Status
Completed
CT.gov ID
NCT05590936
Collaborator
(none)
190
Enrollment
1
Location
2
Arms
59.2
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dimenhydrinate Tablets
  • Drug: Ondansetron iv
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Dec 7, 2022
Actual Study Completion Date :
Dec 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dimenydrinate

Preoperative per os administration of 50 mg dimenydrinate

Drug: Dimenhydrinate Tablets
2 hours preoperative per os administration of 50 mg dimenhydrinate
Other: Ondasentron

Intraoperative intravenous administration of 4 mg ondansetron

Drug: Ondansetron iv
Intraoperative intravenous administration of 4 mg ondansetron

Outcome Measures

Primary Outcome Measures

  1. PONV [30 minutes postoperative]

    PONV recording in patients undergone laparoscopic cholocystectomy

  2. PONV [60 minutes postoperative]

    PONV recording in patients undergone laparoscopic cholocystectomy

  3. PONV [12 hours postoperative]

    PONV recording in patients undergone laparoscopic cholocystectomy

  4. PONV [24 hours postoperative]

    PONV recording in patients undergone laparoscopic cholocystectomy

Secondary Outcome Measures

  1. preoperative anxiety [24 hours before operation]

    preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale

  2. preoperative anxiety [30 minutes before operation]

    preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale

  3. Awaken time [on extubation]

    time from anesthetic drug cessation until extubation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Larisa, Department of Anesthesiology Larissa Thessaly Greece Thessaly

Sponsors and Collaborators

  • University of Thessaly

Investigators

  • Study Chair: Elena Arnaoutoglou, MD, PhD, University of Thessaly
  • Study Director: Konstantinos George Stamoulis, MD, PhD, University Hospital of Larissa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elena Arnaoutoglou, Professor of anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier:
NCT05590936
Other Study ID Numbers:
  • 52699
First Posted:
Oct 21, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ondansetron
Dimenhydrinate

Study Results

No Results Posted as of Dec 8, 2022