Laparoscopic CholecystectomyPhase 3NCT05988671
Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
A Phase 3 study testing normal Saline, Dexamethasone and Dexmedetomidine in people with Laparoscopic Cholecystectomy and Postoperative Nausea and Vomiting, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
Nausea and vomiting are some of the most common complaints of patients after any anesthesia, which is often associated with postop-erative pain. The double-blind clinical trial study aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their combination in reducing postoperative nausea and… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting
- What is being tested?
- normal Saline, Dexamethasone and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Aug 2023to 30 Aug 2024
- Phase
- Phase 3
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged from 20 - 50 years
- ASA I OR II
- undergo laparoscopic cholecystectomy
Who cannot join
- Patients with history of psychotic illnesses,
- Parkinson's disease
- motion disorder
- Smoker
- or history of chemotherapy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparison of Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Clinical Trial
Nausea and vomiting are some of the most common complaints of patients after any anesthesia, which is often associated with postop-erative pain. The double-blind clinical trial study aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their combination in reducing postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
- Being tested
- normal Saline, Dexamethasone, Dexmedetomidine, Combination of dexamethasone + dexmedetomidine
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal SalineDrug
Intraperitoneal route
DexamethasoneDrug
Intraperitoneal route
DexmedetomidineDrug
Intraperitoneal route
Combination of dexamethasone + dexmedetomidineDrug
Intraperitoneal route
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | received 20 ml normal saline Receives: Drug: normal Saline |
| dexamethasone group | Active comparator | received 8mg dexamethasone Receives: Drug: Dexamethasone |
| dexmedetomidine group | Active comparator | received dexmedetomidine 1mic/kg Receives: Drug: Dexmedetomidine |
| combined group | Active comparator | received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg Receives: Drug: Combination of dexamethasone + dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.
Measured: 24 hours postoperative
Secondary outcomes (1)
antiemetic consumption
frequency of antiemetic consumption will be determined
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start10 Aug 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988671
- Sponsor's protocol ID
- RC 10-3-2023
- Status last verified
- Jun 2025
- First submitted
- 4 Aug 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data could be shared upon reasonable request from principal investigator
Publications
Bauiomy H, Kohaf NA, Saad M, Rashed ZF, Abosakaya AM. Study the Effect of Intraperitoneal Dexamethasone, Dexmedetomidine, and Their Combination on PONV After Laparoscopic Cholecystectomy: A Randomized Triple-Blind Trial. Anesthesiol Res Pract. 2025 Feb 24;2025:4976637. doi: 10.1155/anrp/4976637. eCollection 2025.
PubMed 40041104
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05988671
- Acronym / sponsor ID
- RC 10-3-2023
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Nausea and vomiting are some of the most common complaints of patients after any anesthesia, which is often associated with postop-erative pain. The double-blind clinical trial study aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their combination in reducing postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: normal Salinereceived 20 ml normal saline |
| dexamethasone group | Active comparator | Drug: Dexamethasonereceived 8mg dexamethasone |
| dexmedetomidine group | Active comparator | Drug: Dexmedetomidinereceived dexmedetomidine 1mic/kg |
| combined group | Active comparator | Drug: Combination of dexamethasone + dexmedetomidinereceived combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged from 20 - 50 years
- ASA I OR II
- undergo laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- Patients with history of psychotic illnesses,
- Parkinson's disease
- motion disorder
- Smoker
- or history of chemotherapy
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 |
|---|---|---|
| normal SalineIntraperitoneal route | Drug | Control group |
| DexamethasoneIntraperitoneal route | Drug | dexamethasone group |
| DexmedetomidineIntraperitoneal route | Drug | dexmedetomidine group |
| Combination of dexamethasone + dexmedetomidineIntraperitoneal route | Drug | combined group |
Primary outcome
The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.
Time frame: 24 hours postoperative
1 secondary outcome
antiemetic consumption
Time frame: 24 hours postoperatively
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 18 Jun 2025.
- Derived from this study: PubMed 40041104Bauiomy H, Kohaf NA, Saad M, Rashed ZF, Abosakaya AM. Study the Effect of Intraperitoneal Dexamethasone, Dexmedetomidine, and Their Combination on PONV After Laparoscopic Cholecystectomy: A Randomized Triple-Blind Trial. Anesthesiol Res Pract. 2025 Feb 24;2025:4976637. doi: 10.1155/anrp/4976637. eCollection 2025.
- Individual participant dataSharing planned: Yes. data could be shared upon reasonable request from principal investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing normal Saline, Dexamethasone and Dexmedetomidine in people with Laparoscopic Cholecystectomy and Postoperative Nausea and Vomiting, run by Al-Azhar University at 2 sites in Egypt.
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 5 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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number of patients suffered from postoperative nausea and vomiting will be recorded in each group. (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05988671, which also lists 1 linked publication.
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 18 Jun 2025.