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NCT04518618
Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S
NA trial testing Fentanyl in Pruritis in 96 participants. Completed in 7 March 2021.
7 March 2021
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 96 |
| Start date | 11 September 2020 |
| Primary completion | 7 March 2021 |
| Estimated completion | 7 March 2021 |
| Sites | 2 locations across Egypt |
Drugs / interventions tested
Conditions studied
- Pruritis — all drugs for Pruritis →
Sponsor
Tanta University
Who can join
Adults 21 to 30, female only, with Pruritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:- * Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml). * Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone. The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S. Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04518618
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Pruritis
Currently open trials in the same condition.
- NCT06226610 — Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic · Phase 2 · recruiting
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 NCT04518618 (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 March 2021
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/NCT04518618.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing