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NCT01837290
The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery
Phase 3 trial testing dexmedetomidine infusion for premedication in Chronic Renal Failure in 60 participants. Completed in 1 January 2014.
1 January 2014
Quick facts
| Lead sponsor | Baskent University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Enrollment | 60 |
| Start date | 1 December 2012 |
| Primary completion | 1 January 2014 |
| Estimated completion | 1 January 2014 |
| Sites | 3 locations across Turkey (Türkiye) |
Drugs / interventions tested
- dexmedetomidine infusion for premedication — full drug profile →
- Midazolam (midazolam) — full drug profile →
- saline infusion — full drug profile →
- Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg — full drug profile →
Conditions studied
- Chronic Renal Failure — all drugs for Chronic Renal Failure →
- Hip Fracture — all drugs for Hip Fracture →
Sponsor
Baskent University
Who can join
Adults 65 to 95, any sex, with Chronic Renal Failure or Hip Fracture. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Decrease at the propofol doses and postoperative early recovery
Time frame: up to first 6 hours for postoperative pain management
In addition patients will be followed postoperatively first 6 hours for postoperative pain management at the ward.
Sponsor's own description
Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be required for geriatric patients with end stage renal disease. These patients have severe comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the perioperative period. For this reasons a careful anesthesia plan should be planned and performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine position with a fracture table. Intraoperative sedation might be necessary for patients under regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist that is being used as an agent for its sedative and adjuvant analgesic effects. The aim of this study is to evaluate the effects of dexmedetomidine premedication on geriatric patients with end stage renal disease, who will be undergoing a surgical operation for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral Index) guided sedation with intraoperative propofol infusion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01837290
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Baskent University 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 NCT01837290 (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 Baskent University
- Last refreshed: 26 January 2015
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/NCT01837290.
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