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NCT04438811
Task-based Credentialing for Medical Officers in Spinal Anesthesia
NA trial testing delivery of the spinal anesthetic by a trained medical officer in Spinal Anesthesia in 486 participants. Completed in 1 March 2021.
10 January 2021
Quick facts
| Lead sponsor | Harvard Medical School (HMS and HSDM) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 486 |
| Start date | 1 March 2019 |
| Primary completion | 10 January 2021 |
| Estimated completion | 1 March 2021 |
| Sites | 4 locations across United States, India |
Drugs / interventions tested
- delivery of the spinal anesthetic by a trained medical officer
- delivery of spinal anesthetic by a consultant anesthetist
Conditions studied
- Spinal Anesthesia — all drugs for Spinal Anesthesia →
- Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care — all drugs for Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care →
Sponsor
Harvard Medical School (HMS and HSDM)
Who can join
Adults 18 to 65, any sex, with Spinal Anesthesia or Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Test the safety and effectiveness of training medical officers in the provision of spinal anesthesia in a rural hospital context using a non-inferiority randomized trial. The safety and effectiveness of the MOs will be evaluated through a non-inferiority trial in which patients are randomized to care by a trained MO or an anesthesiologist. The primary outcomes are safety (adherence to adapted anesthesia safety checklist- see supporting documents "Adapted Anesthesia Safety Checklist") and effectiveness (adequate analgesia) of spinal anesthesia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Task-sharing spinal anaesthesia care in three rural Indian hospitals: a non-inferiority randomised controlled clinical trial.
Menon N, George R, Kataria R, Manoharan R, et al · · 2024 · cited 3× · PMID 39153752 · DOI 10.1136/bmjgh-2023-014170
Verify or expand the search:
- PubMed search for NCT04438811
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Spinal Anesthesia
Currently open trials in the same condition.
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- NCT07339475 — Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Sp · recruiting
- NCT07256548 — Machine Learning for Predicting Spinal Anesthesia Duration · recruiting
Other Harvard Medical School (HMS and HSDM) 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 NCT04438811 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harvard Medical School (HMS and HSDM)
- Last refreshed: 29 April 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/NCT04438811.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing