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Intraoperative clonidine for postoperative pain management in patients undergoing spine surgery: a prospective, randomized, blinded, placebo-controlled trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505969-80-00
Enrollment
120
Registered
2023-08-29
Start date
2023-09-05
Completion date
2024-03-12
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative spine diseases

Brief summary

The primary outcome is postoperative opioid consumption within the first 3 hours after arrival at the PACU

Detailed description

Postoperative opioid consumption within the first 6 hours after arrival at the PACU, Daily opioid consumption after 1 month, Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10), Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsey Sedation Score 1-6), Nausea and/or vomiting at 0, 60, and 120 minutes after arrival at the PACU (yes/no), Time for discharge from the PACU, Length of hospital stay

Interventions

DRUGNatriumklorid Fresenius Kabi 9 mg/ml
DRUGClotaxip
DRUGinjektionsvæske
DRUGopløsning
DRUGNatriumklorid 9 mg/ml "Fresenius Kabi"
DRUGsolvens til parenteralt brug

Sponsors

Aarhus Universitetshospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary outcome is postoperative opioid consumption within the first 3 hours after arrival at the PACU—

Secondary

MeasureTime frame
Postoperative opioid consumption within the first 6 hours after arrival at the PACU, Daily opioid consumption after 1 month, Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10), Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsey Sedation Score 1-6), Nausea and/or vomiting at 0, 60, and 120 minutes after arrival at the PACU (yes/no), Time for discharge from the PACU, Length of hospital stay—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026