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NCT03775876
Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy
Phase 4 trial testing Shoulder Arthroscopy in Hemodynamic in 60 participants. Completed in 15 September 2018.
1 March 2018
Quick facts
| Lead sponsor | Saint-Joseph University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 1 March 2017 |
| Primary completion | 1 March 2018 |
| Estimated completion | 15 September 2018 |
| Sites | 1 location across Lebanon |
Drugs / interventions tested
- Shoulder Arthroscopy
- Regional Block — full drug profile →
- Propofol (Propofol) — full drug profile →
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- BIS
Conditions studied
- Hemodynamic — all drugs for Hemodynamic →
- Sedation — all drugs for Sedation →
- Satisfaction, Personal — all drugs for Satisfaction, Personal →
Sponsor
Saint-Joseph University
Who can join
Adults 18 to 80, any sex, with Hemodynamic or Sedation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Operative shoulder arthroscopy under regional block anesthesia often presents with hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure is required to minimize the bleeding. Regional anesthesia is successfully performed to many patients in whom tracheal intubation or the placement of a laryngeal tube is undesired. Propofol has traditionally been used to provide sedation in patients undergoing shoulder arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on blood pressure, the investigators set out to compare intraoperative hemodynamics of both drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators also assessed whether the type of anesthetic agent used for sedation accounted for other differences in intra and post-operative outcome measures.
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 NCT03775876
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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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 NCT03775876 (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 Saint-Joseph University
- Last refreshed: 17 December 2018
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/NCT03775876.
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