Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia

NCT04313374 | Completed Phase 4

• 1 other identifier: Cerrahpasa Neuroanaesthesia
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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

Brain Tumors

Keywords

Integrated pulmonary index, opioid side effects

Outcome Measures

Primary Outcomes (1)

• Integrated pulmonary index system

  Integrated pulmonary index system will be used to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy. This software tool is a single index value ranging from 1 to 10 based on 4 physiological parameters: end tidal carbon dioxide, respiratory rate, oxygen saturation, pulse rate.

  24 hour postoperatively

Study Arms (3)

Morphine PCA 1 mg

ACTIVE COMPARATOR

The patient controlled analgesia device give 1mg morphine for each demand of the patient.

Drug: Morphine PCA 1 mg

Morphine PCA 0,5 mg

ACTIVE COMPARATOR

The patient controlled analgesia device give 0,5 mg morphine for each demand of the patient.

Drug: Morphine PCA 0,5 mg

Placebo

PLACEBO COMPARATOR

The patient controlled analgesia device give 2 mL serum physiologic for each demand of the patient.The Group 3 will take 50 mg dexketoprofen in the recovery room. Intra venous injections of dexketoprofen will repeat every 8 hours. If the VAS skore more than 4 the Group 3 patients will take 1 g paracetamol every 6 hours.

Drug: Placebo

Interventions

Morphine PCA 1 mg DRUG

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.

Also known as: Morphine sulphate 1 mg

Morphine PCA 1 mg

Morphine PCA 0,5 mg DRUG

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.

Also known as: Morphine sulphate 0,5 mg

Morphine PCA 0,5 mg

Placebo DRUG

the PCA will contain placebo

Also known as: serum physiologic, dexketoprofen trometamol, paracetamol

Placebo

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Conscious patients
• Elective supratentorial craniotomies
• ASA I-III

You may not qualify if:

• Unconscious postoperatively
• Chronic pain
• Opioid, dexketoprofen or paracetamol allergy
• Delirium
• Renal insufficiency
• Alcohol, opioid dependency
• Transsphenoidal pituitary surgery

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Cerrahpasa Medical School

Istanbul, 34304, Turkey (Türkiye)

Location

Related Publications (3)

• 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: 17410701 BACKGROUND

• Thibault M, Girard F, Moumdjian R, Chouinard P, Boudreault D, Ruel M. Craniotomy site influences postoperative pain following neurosurgical procedures: a retrospective study. Can J Anaesth. 2007 Jul;54(7):544-8. doi: 10.1007/BF03022318.

  PMID: 17602040 BACKGROUND

• Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600.

  PMID: 20479664 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Morphine; dexketoprofen trometamol; Acetaminophen

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yusuf Tunali, Professor

  Cerrahpasa Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the patient, the investigator of the study will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SPECİALİST ANESTHESİOLOGİST

Model Details: parallel assignment

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 18, 2020
• Study Start: August 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)