Dimenydrinate vs Ondansetron for PONV (DONV) (DONV)

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

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 Overview

• Status: Completed
• Conditions: PONV in Laparoscopic Cholocystectomies
• Intervention / Treatment: Drug: Dimenhydrinate Tablets; Drug: Ondansetron iv

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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, Thessaly
      • University Hospital of Larisa, Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV	PONV recording in patients undergone laparoscopic cholocystectomy	30 minutes postoperative
PONV	PONV recording in patients undergone laparoscopic cholocystectomy	60 minutes postoperative
PONV	PONV recording in patients undergone laparoscopic cholocystectomy	12 hours postoperative
PONV	PONV recording in patients undergone laparoscopic cholocystectomy	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative anxiety	preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale	24 hours before operation
preoperative anxiety	preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale	30 minutes before operation
Awaken time	time from anesthetic drug cessation until extubation	on extubation

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Director: Konstantinos George Stamoulis, MD, PhD, University Hospital Of Larissa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Ondansetron; Dimenhydrinate
• Other Study ID Numbers: 52699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No