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NCT05884229
The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia on Opioid Consumption in Gastric Sleeve Surgery
NA trial testing Intra-operative analgesia guided by SPI in Intraoperative Monitoring in 40 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Iuliu Hatieganu University of Medicine and Pharmacy |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 1 January 2023 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across Romania |
Drugs / interventions tested
- Intra-operative analgesia guided by SPI
Conditions studied
- Intraoperative Monitoring — all drugs for Intraoperative Monitoring →
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Who can join
Adults 18 to 65, any sex, with Intraoperative Monitoring. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a unicentric, prospective randomised trial that aims to evaluate the role of intra-operative monitoring of nociception through SPI (Surgical Pleth Index) in guiding analgesia and reducing opioid consumption in obese patients undergoing bariatric surgery. We aim to enrol 40 patients having laparoscopic gastric sleeve surgery in the Cluj-Napoca County Hospital. They will be randomised into two groups, one with opioid administration during surgery guided by SPI, and the other one guided by anesthetist experience. We will monitor opioid consumption, pain scores during the first 90 minutes post-operatively, hemodinamic events during surgery and the duration between reversal of neuromuscular block and extubation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Influence of Surgical Pleth Index-Guided Versus Conventional Analgesia on Opioid Consumption During Gastric Sleeve Surgery: A Pilot Study.
Leahu CE, Petrisor C, Cocu S, Boldis AM, et al · · 2025 · PMID 41157243 · DOI 10.3390/life15101570
Verify or expand the search:
- PubMed search for NCT05884229
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05884229 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Iuliu Hatieganu University of Medicine and Pharmacy
- Last refreshed: 1 June 2023
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/NCT05884229.
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