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NCT06017167
Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Phase 2 trial testing Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . in Postoperative Nausea and Vomiting in 70 participants. Status unknown.
1 September 2023
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 15 September 2022 |
| Primary completion | 1 September 2023 |
| Estimated completion | 1 October 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline . — full drug profile →
- Ondansetron 4mg + dexamethasone 8mg + normal saline. — full drug profile →
Conditions studied
- Postoperative Nausea and Vomiting — all drugs for Postoperative Nausea and Vomiting →
- Laparoscopic Cholecystectomy — all drugs for Laparoscopic Cholecystectomy →
Sponsor
Tanta University
Who can join
Adults 18 to 65, female only, with Postoperative Nausea and Vomiting or Laparoscopic Cholecystectomy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
Time frame: through out 24 hours after surgery.
The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.
Sponsor's own description
The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group. The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy. The secondary outcomes are: * The severity of post operative nausea and vomiting. * Use of rescue antiemetic drugs. * Postoperative pain and sedation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06017167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06632184 — Peritoneal Lavage Using Saline or Saline With Ondansetron for Pain Control After Laparoscopic Cholecystectomy · Phase 4 · active not recruiting
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Other Tanta University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06017167 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tanta University
- Last refreshed: 26 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06017167.
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