Dimenydrinate vs Ondansetron for PONV (DONV)

NCT05590936 | Completed

• 1 other identifier: 52699
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

PONV in Laparoscopic Cholocystectomies

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• preoperative anxiety

  24 hours before operation

• preoperative anxiety

  30 minutes before operation

• Awaken time

  on extubation

Study Arms (2)

Dimenydrinate

ACTIVE COMPARATOR

Preoperative per os administration of 50 mg dimenydrinate

Drug: Dimenhydrinate Tablets

Ondasentron

OTHER

Intraoperative intravenous administration of 4 mg ondansetron

Drug: Ondansetron iv

Interventions

Dimenhydrinate Tablets DRUG

2 hours preoperative per os administration of 50 mg dimenhydrinate

Dimenydrinate

Ondansetron iv DRUG

Intraoperative intravenous administration of 4 mg ondansetron

Ondasentron

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, Thessaly, Greece

Location

MeSH Terms

Interventions

Dimenhydrinate

Intervention Hierarchy (Ancestors)

Diphenhydramine; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Elena Arnaoutoglou, MD, PhD

  University of Thessaly

  STUDY CHAIR

• Konstantinos George Stamoulis, MD, PhD

  University Hospital of Larissa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesiology

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: January 1, 2018
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

GR (1)