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NCT04313374

Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia

Completed Phase 4 Last updated 18 March 2020
What this trial tests

Phase 4 trial testing Morphine PCA 1 mg in Brain Tumors in 90 participants. Completed in 1 August 2018.

Timeline
1 August 2016
Primary endpoint
1 May 2018
1 August 2018

Quick facts

Lead sponsorIstanbul University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment90
Start date1 August 2016
Primary completion1 May 2018
Estimated completion1 August 2018
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Brain Tumors

Currently open trials in the same condition.

Other Istanbul University trials

Trials by the same sponsor.

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Data sources for this page

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