Dimenydrinate vs Ondansetron for PONV (DONV)

University of Thessaly190 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

190

Conditions

PONV in Laparoscopic Cholocystectomies

Interventions

Dimenhydrinate TabletsDRUG

2 hours preoperative per os administration of 50 mg dimenhydrinate

Ondansetron ivDRUG

Intraoperative intravenous administration of 4 mg ondansetron

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, Greece

Outcomes

Primary Outcomes

PONV

PONV recording in patients undergone laparoscopic cholocystectomy

Time frame: 30 minutes postoperative

PONV

PONV recording in patients undergone laparoscopic cholocystectomy

Time frame: 60 minutes postoperative

PONV

PONV recording in patients undergone laparoscopic cholocystectomy

Time frame: 12 hours postoperative

PONV

PONV recording in patients undergone laparoscopic cholocystectomy

Time frame: 24 hours postoperative

Secondary Outcomes

preoperative anxiety

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

Time frame: 24 hours before operation

preoperative anxiety

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

Time frame: 30 minutes before operation

Awaken time

time from anesthetic drug cessation until extubation

Time frame: on extubation

Data from ClinicalTrials.gov

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