Supratentorial Neoplasms Clinical Trial
Official title:
Comparison of Efficacy and Safety of the Postoperative Analgesia Methods for Supratentorial Craniotomy by Integrated Pulmonary Index (IPI)
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. In a previous study, 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 the 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 PCA and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of supratentorial neoplasms Exclusion Criteria: - Neurological disorders hindering the communication, aphasia, Glasgow Coma Score (GCS) less than 15, drug or alcohol addiction, chronic pain, raised intracranial pressure, allergies to any of the drugs used in this study, hepatic or renal dysfunction, peptic ulcer disease, dementia. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Ozlem Korkmaz Dilmen | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4. — View Citation
Garah J, Adiv OE, Rosen I, Shaoul R. The value of Integrated Pulmonary Index (IPI) monitoring during endoscopies in children. J Clin Monit Comput. 2015 Dec;29(6):773-8. doi: 10.1007/s10877-015-9665-z. Epub 2015 Feb 11. — View Citation
Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Integrated Pulmonary Index (IPI) | Change from Beseline IPI values in postoperative first 24 hours.(at 10th minute, 1, 2, 6, 12, and 24 hours post dose) | Yes | |
Secondary | Pain intensity measured by Visual Analog Score | Change from Beseline Pain Intensity in postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose) | Yes | |
Secondary | Sedation level measured by Ramsay score | Change from Beseline Sedation Level in postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose) | Yes | |
Secondary | Cumulative Morphine consumption | Change from Baseline in 1postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose) | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04607525 -
Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy
|
Phase 4 | |
Completed |
NCT00389883 -
Anaesthesia for Supratentorial Tumor Resection
|
Phase 3 | |
Completed |
NCT00972790 -
Scalp Nerve Blocks for Post-Craniotomy Pain
|
N/A | |
Completed |
NCT00179803 -
Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors
|
Phase 2 | |
Recruiting |
NCT04316208 -
Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure
|
N/A | |
Recruiting |
NCT02168075 -
Mannitol Brain Relaxation Effect
|
N/A | |
Completed |
NCT04941040 -
Opioid Free VS Opioid Anesthesia for Craniotomies
|
Phase 1 | |
Completed |
NCT02593942 -
Remifentanil Infusion Alone During the Closure Period for Early Emergence Following Craniotomy
|
Phase 4 | |
Recruiting |
NCT02113358 -
Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
|
N/A | |
Not yet recruiting |
NCT04344132 -
Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
|
N/A |