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NCT04313374
Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia
Phase 4 trial testing Morphine PCA 1 mg in Brain Tumors in 90 participants. Completed in 1 August 2018.
1 May 2018
Quick facts
| Lead sponsor | Istanbul University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 August 2016 |
| Primary completion | 1 May 2018 |
| Estimated completion | 1 August 2018 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Morphine PCA 1 mg — full drug profile →
- Morphine PCA 0,5 mg — full drug profile →
- Placebo
Conditions studied
- Brain Tumors — all drugs for Brain Tumors →
Sponsor
Istanbul University
Who can join
Adults 16 to 70, any sex, with Brain Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An optimal analgesic therapy is very important for postoperative recovery. In recent years, several studies showed that the prevalence of the moderate to severe pain after craniotomy ranged from 69 to 87% of patients. The investigators showed that the use of morphine based patient controlled analgesia prevented moderate to severe postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid related side effects in the intensive care unit for 24 hours following surgery in our previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates respiratory and hemodynamic parameters noninvasively. In the present study the investigators will use different doses of morphine based patient-controlled analgesia and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy.
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 NCT04313374
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Other Istanbul 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 NCT04313374 (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 Istanbul University
- Last refreshed: 18 March 2020
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/NCT04313374.
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