NCT02929147

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 6, 2016

Last Update Submit

October 10, 2016

Conditions

Supratentorial Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • 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)

  • 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)

  • Cumulative Morphine consumption

    Change from Baseline in 1postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)

Study Arms (3)

Morphine 1 mg

EXPERIMENTAL

In the Group 1 the 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

Morphine 0.5

EXPERIMENTAL

In the Group 2 the 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: Morphine

Dexketoprofen & Placebo

ACTIVE COMPARATOR

The Group 3 will take 50 mg dexketoprofen in the recovery room. Intra venous injections of dexketoprofen will repeat every 8 hours.

Drug: DexketoprofenDrug: Placebo

Interventions

MorphineDRUG

In the Group 1 the 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. In the Group 2 the 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.

Morphine 0.5Morphine 1 mg
DexketoprofenDRUG

The Group 3 will take 50 mg dexketoprofen in the recovery room. Intra venous injections of dexketoprofen will repeat every 8 hours.

Also known as: Arveles
Dexketoprofen & Placebo
PlaceboDRUG

In the Group 3 the PCA will contain placebo.

Also known as: SF
Dexketoprofen & Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of supratentorial neoplasms

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozlem Korkmaz Dilmen

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 27164511BACKGROUND

  • 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. doi: 10.3171/jns.2007.106.2.210.

    PMID: 17410701BACKGROUND

  • 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.

    PMID: 25666393BACKGROUND

  • Akcil EF, Korkmaz Dilmen O, Ertem Vehid H, Yentur E, Tunali Y. The role of "Integrated Pulmonary Index" monitoring during morphine-based intravenous patient-controlled analgesia administration following supratentorial craniotomies: a prospective, randomized, double-blind controlled study. Curr Med Res Opin. 2018 Nov;34(11):2009-2014. doi: 10.1080/03007995.2018.1501352. Epub 2018 Aug 5.

    PMID: 30010438DERIVED

MeSH Terms

Conditions

Supratentorial Neoplasms

Interventions

Morphinedexketoprofen trometamol

Condition Hierarchy (Ancestors)

Brain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Ozlem Korkmaz Dilmen, MD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozlem Korkmaz Dilmen, MD

CONTACT

+902124143435korkmazdilmen@gmail.com

Yusuf Tunali, MD

CONTACT

+902124143000ytunali@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DESA, Associate Prof. in Anesthesiology

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 11, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

TU(1)