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NCT03319004
Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia
NA trial testing apply phase lag entropy sensor in Surgery Requiring Spinal Anesthesia in 27 participants. Status unknown.
31 January 2018
Quick facts
| Lead sponsor | Gangnam Severance Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 27 |
| Start date | 19 July 2017 |
| Primary completion | 31 January 2018 |
| Estimated completion | 18 July 2018 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- apply phase lag entropy sensor
Conditions studied
- Surgery Requiring Spinal Anesthesia — all drugs for Surgery Requiring Spinal Anesthesia →
Sponsor
Gangnam Severance Hospital
Who can join
Adults 20 to 50, any sex, with Surgery Requiring Spinal Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
For verifying the phase lag entropy as the tool for measurement of level of consciousness, the investigators compared phase lag entropy to bispectral index. Using Target-Controlled Infusion pump, propofol was infused for sedation during the spinal anesthesia. The investigators measured Observer's Assessment of Alertness/Sedation Scale as the propofol concentration rises. At the same time, The investigators observed phase lag entropy score and bispectral index score.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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 NCT03319004 (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 Gangnam Severance Hospital
- Last refreshed: 24 October 2017
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/NCT03319004.
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