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Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia

NCT04313374 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-03-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Morphine PCA 1 mg

PCA will set to administer a bolus dose of 1 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours.

DRUG

Morphine PCA 0,5 mg

PCA set to administer a bolus dose of 0.5 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours.

DRUG

Placebo

the PCA will contain placebo

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Yusuf Tunali, Professor · Cerrahpasa Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2018-05-01
Completion
2018-08-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04313374 on ClinicalTrials.gov