Dimenydrinate vs Ondansetron for PONV (DONV)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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PONV in Laparoscopic Cholocystectomies

Intervention / Treatment
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* Drug: Dimenhydrinate Tablets
* Drug: Ondansetron iv


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dimenydrinate<br>Preoperative per os administration of 50 mg dimenydrinate | Drug: Dimenhydrinate Tablets<br>* 2 hours preoperative per os administration of 50 mg dimenhydrinate<br>|
| Other: Ondasentron<br>Intraoperative intravenous administration of 4 mg ondansetron | Drug: Ondansetron iv<br>* Intraoperative intravenous administration of 4 mg ondansetron<br>|

What is the study measuring?
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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 |