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NCT06040307: GORA
Guiding Opioid Administration in Patients With Regional Anesthesia
NA trial testing SPI (Surgical Pleth Index) in Nociceptive Pain in 80 participants. Completed in 6 May 2024.
9 April 2024
Quick facts
| Lead sponsor | Universitätsklinikum Hamburg-Eppendorf |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 18 December 2023 |
| Primary completion | 9 April 2024 |
| Estimated completion | 6 May 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- SPI (Surgical Pleth Index)
Conditions studied
- Nociceptive Pain — all drugs for Nociceptive Pain →
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Analgesia — all drugs for Analgesia →
- Anesthesia Recovery Period — all drugs for Anesthesia Recovery Period →
Sponsor
Universitätsklinikum Hamburg-Eppendorf — full company profile →
Who can join
18 and older, any sex, with Nociceptive Pain or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
General anesthesia is a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high potency opioids in order to achieve antinociception during surgery is combining a general anesthesia with a regional anesthesia. Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed. In the current clinical practice, the opioid dosage is usually chosen by clinical judgment. Recently different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. One of the first commercially available nociception indices was the Surgical Pleth Index (SPI) derived by the CARESCAPE™B650 patient monitor (GE Healthcare). Until today, it remains unknown whether guiding sufentanil administration by SPI monitoring affects the administered amount of intraoperative and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative recovery in patients with a combination of general and regional anesthesia. This study aims to investigate whether guiding sufentanil administration by SPI monitoring - compared to routine care - reduces intraoperative sufentanil consumption in patients having trauma and orthopaedic surgery with a combination of general and regional anesthesia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Opioid administration guided by Surgical Pleth Index in patients with a combination of general and regional anaesthesia during trauma and orthopaedic surgery: a double-blind, randomised controlled trial.
Koschmieder KC, Pinnschmidt HO, Borst LS, Greiwe G, et al · · 2026 · cited 1× · PMID 41042488 · DOI 10.1007/s10877-025-01363-2
Verify or expand the search:
- PubMed search for NCT06040307
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06040307 (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 Universitätsklinikum Hamburg-Eppendorf
- Last refreshed: 13 May 2024
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/NCT06040307.
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