PONV in Laparoscopic CholocystectomiesDONVNCT05590936
Dimenydrinate vs Ondansetron for PONV (DONV)
A study testing Dimenhydrinate Tablets and Ondansetron iv in people with PONV in Laparoscopic Cholocystectomies, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PONV in Laparoscopic Cholocystectomies
- What is being tested?
- Dimenhydrinate Tablets and Ondansetron iv
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2018to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old
- ASA PS I-III
- Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Larisa, Department of Anesthesiology
Larissa, Thessaly, Thessaly
About this study
Official title: Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting
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.
Read the detailed 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.
- Conditions
- PONV in Laparoscopic Cholocystectomies
- Being tested
- Dimenhydrinate Tablets, Ondansetron iv
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimenhydrinate TabletsDrug
2 hours preoperative per os administration of 50 mg dimenhydrinate
Ondansetron ivDrug
Intraoperative intravenous administration of 4 mg ondansetron
| Study group | Role | What they receive |
|---|---|---|
| Dimenydrinate | Active comparator | Preoperative per os administration of 50 mg dimenydrinate Receives: Drug: Dimenhydrinate Tablets |
| Ondasentron | Other | Intraoperative intravenous administration of 4 mg ondansetron Receives: Drug: Ondansetron iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV
PONV recording in patients undergone laparoscopic cholocystectomy
Measured: 30 minutes postoperative
PONV
PONV recording in patients undergone laparoscopic cholocystectomy
Measured: 60 minutes postoperative
PONV
PONV recording in patients undergone laparoscopic cholocystectomy
Measured: 12 hours postoperative
PONV
PONV recording in patients undergone laparoscopic cholocystectomy
Measured: 24 hours postoperative
Secondary outcomes (3)
preoperative anxiety
preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale
Measured: 24 hours before operation
preoperative anxiety
preoperative anxiety recording in patients undergone laparoscopic cholocystectomy measured by one hundred points scale
Measured: 30 minutes before operation
Awaken time
time from anesthetic drug cessation until extubation
Measured: on extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Jan 2018
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONV in Laparoscopic CholocystectomiesStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Elena Arnaoutoglou, MD, PhD, Study chair, University of ThessalyKonstantinos George Stamoulis, MD, PhD, Study director, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590936
- Sponsor's protocol ID
- 52699
- Acronym
- DONV
- Status last verified
- Dec 2022
- First submitted
- 18 Oct 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT05590936
- Acronym / sponsor ID
- DONV / 52699
- Conditions
- PONV in Laparoscopic Cholocystectomies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dimenydrinate | Active comparator | Drug: Dimenhydrinate TabletsPreoperative per os administration of 50 mg dimenydrinate |
| Ondasentron | Other | Drug: Ondansetron ivIntraoperative intravenous administration of 4 mg ondansetron |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years old
- ASA PS I-III
- Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimenhydrinate Tablets2 hours preoperative per os administration of 50 mg dimenhydrinate | Drug | Dimenydrinate |
| Ondansetron ivIntraoperative intravenous administration of 4 mg ondansetron | Drug | Ondasentron |
Primary outcome
PONV
Time frame: 30 minutes postoperative
PONV recording in patients undergone laparoscopic cholocystectomy
PONV
Time frame: 60 minutes postoperative
PONV recording in patients undergone laparoscopic cholocystectomy
PONV
Time frame: 12 hours postoperative
PONV recording in patients undergone laparoscopic cholocystectomy
PONV
Time frame: 24 hours postoperative
PONV recording in patients undergone laparoscopic cholocystectomy
3 secondary outcomes
preoperative anxiety
Time frame: 24 hours before operation
preoperative anxiety
Time frame: 30 minutes before operation
Awaken time
Time frame: on extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for PONV in Laparoscopic Cholocystectomies
Recruiting
Effect of Preoperative Melatonin on Quality of Recovery After Elective Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy, Postoperative Quality of Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Arnaoutoglou, MD, PhD study chair
University of Thessaly
Konstantinos George Stamoulis, MD, PhD study director
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dimenhydrinate Tablets and Ondansetron iv in people with PONV in Laparoscopic Cholocystectomies, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV (time frame: 30 minutes postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.