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NCT Number: NCT05590936

Dimenydrinate vs Ondansetron for PONV (DONV)

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.

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Key information

Conditions

PONV in Laparoscopic Cholocystectomies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dimenhydrinate Tablets

Drug

2 hours preoperative per os administration of 50 mg dimenhydrinate

Ondansetron iv

Drug

Intraoperative intravenous administration of 4 mg ondansetron

Primary outcomes

  1. PONV

    Time frame: 30 minutes postoperative

    PONV recording in patients undergone laparoscopic cholocystectomy

  2. PONV

    Time frame: 60 minutes postoperative

    PONV recording in patients undergone laparoscopic cholocystectomy

  3. PONV

    Time frame: 12 hours postoperative

    PONV recording in patients undergone laparoscopic cholocystectomy

  4. PONV

    Time frame: 24 hours postoperative

    PONV recording in patients undergone laparoscopic cholocystectomy

Secondary outcomes

  1. preoperative anxiety

    Time frame: 24 hours before operation

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

  2. preoperative anxiety

    Time frame: 30 minutes before operation

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

  3. Awaken time

    Time frame: on extubation

    time from anesthetic drug cessation until extubation

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Acronym: DONV

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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