Trials Sponsors Conditions Drugs Pricing

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 TabletsDrug

2 hours preoperative per os administration of 50 mg dimenhydrinate

Dimenydrinate

Ondansetron ivDrug

Intraoperative intravenous administration of 4 mg ondansetron

Ondasentron

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18-75 years old
ASA PS I-III

Sponsors & Collaborators

University of Thessaly
Otherlead

Study Sites (1)

University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, Thessaly, Greece

MeSH Terms

Interventions

Dimenhydrinate

Intervention Hierarchy (Ancestors)

DiphenhydramineEthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTheophyllineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-Ring

Study Officials

Elena Arnaoutoglou, MD, PhD
University of Thessaly
STUDY CHAIR
Konstantinos George Stamoulis, MD, PhD
University Hospital of Larissa
STUDY DIRECTOR

Enrollment

190 participants (actual enrollment reported by the registry).

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

Actual (reported)

Dimenydrinate vs Ondansetron for PONV (DONV)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (2)

Dimenydrinate

Ondasentron

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (2)

Dimenydrinate

Ondasentron

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations