Dimenydrinate vs Ondansetron for PONV (DONV)

University of Thessaly

Status: Completed

Conditions: PONV in Laparoscopic Cholocystectomies

Treatments: Drug: Dimenhydrinate Tablets; Drug: Ondansetron iv

Study type: Interventional

Funder types: Other

Identifiers

NCT05590936

52699

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 2 patient groups

Dimenydrinate

Active Comparator group

Description:

Preoperative per os administration of 50 mg dimenydrinate

Treatment:

Drug: Dimenhydrinate Tablets

Ondasentron

Other group

Description:

Intraoperative intravenous administration of 4 mg ondansetron

Treatment:

Drug: Ondansetron iv