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NCT03569046
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries
NA trial testing local anaesthetic injection in Tympanum; Perforation in 80 participants. Completed in 30 December 2018.
1 December 2018
Quick facts
| Lead sponsor | Abd-Elazeem Abd-Elhameed Elbakry |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 80 |
| Start date | 6 July 2018 |
| Primary completion | 1 December 2018 |
| Estimated completion | 30 December 2018 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- local anaesthetic injection — full drug profile →
- Normal Saline Flush, 0.9% Injectable Solution — full drug profile →
- general anesthetic — full drug profile →
- Hypotensives — full drug profile →
Conditions studied
- Tympanum; Perforation — all drugs for Tympanum; Perforation →
Sponsor
Abd-Elazeem Abd-Elhameed Elbakry — full company profile →
Who can join
Adults 18 to 60, any sex, with Tympanum; Perforation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Proper selection of anesthetic technique is important in middle ear microsurgery. Controlled hypotension in ear surgery decreases blood loss with improved quality of the surgical field, however, it is associated with resistance to vasodilators and delayed recovery from anesthesia. The use of local anesthetic technique alone in middle ear surgery decreases bleeding and reduces postoperative pain, however, pain on injection, noise, and head-neck position had been reported with the increased risk of patient injuries. This study aimed to compare the effects of local ear block combined with general anesthesia versus general anesthesia alone, regarding intraoperative hemodynamics, anesthetic consumption, recovery characteristics, postoperative pain, adverse effects and postoperative complications.
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 NCT03569046
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other recruiting trials for Tympanum; Perforation
Currently open trials in the same condition.
- NCT06408363 — Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions · NA · recruiting
Other Abd-Elazeem Abd-Elhameed Elbakry trials
Trials by the same sponsor.
- NCT03735368 — Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery · Phase 2 · completed
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 NCT03569046 (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 Abd-Elazeem Abd-Elhameed Elbakry
- Last refreshed: 25 April 2019
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/NCT03569046.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing