Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia

• Sponsor: Istanbul University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04313374
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumors	Drug: Morphine PCA 1 mg; Drug: Morphine PCA 0,5 mg; Drug: Placebo	Phase 4

Detailed 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. In our 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 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.

90 patients will randomize in 3 groups following supratentorial craniotomy. All patients will previously instruct on the patient-controlled analgesia pumps (Abbott Provider, Chicago, USA) and visual analogue scale (VAS) from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. All patients will use patient-controlled analgesia pumps for 24 hours following supratentorial craniotomy. In the Group 1 the patient-controlled analgesia pump 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 patient-controlled analgesia pump will 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. In the Group 3 the patient-controlled analgesia pump will contain placebo. 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 score will more than 4 the Group 3 patients will take 1 g paracetamol every 6 hours.

All patients will be observed by the Integrated Pulmonary Index (IPI). It is a new device that provides to recognise in a patients respiratory status. 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. Patients will asses at 10th minute, 1, 2, 6, 12, and 24 hours postoperatively. Sedation will evaluate according to Ramsay score 20. VAS scores, total morphine consumption, Ramsay score, blood pressure, heart rate and respiratory rate, the IPI score will record at each time pain will evaluate. Postoperative side effects, including rash, pruritus, nausea and vomiting will record at the same intervals and defined by a scale with 0 = absent or 1 = present. Moreover the lowest IPI score, the apnea count (longer than 30 seconds) and the count of the desaturation events will record in the postoperative 24 hours.

The 3 Groups will compare with respect to VAS scores, morphine consumption, IPI scores, the apnea count, the desaturation events and morphine related side effects during the 24 hours following supratentorial craniotomy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel assignmentparallel assignment
• Masking: Double (Participant, Investigator)
• Masking Description: the patient, the investigator of the study will be blinded
• Primary Purpose: Treatment
• Official Title: Effective and Safe Morphine Dose for Patient Controlled Anesthesia in Supratentorial Craniotomies
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Morphine PCA 1 mg The patient controlled analgesia device give 1mg morphine for each demand of the patient.	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.; Other Names: Morphine sulphate 1 mg
Active Comparator: Morphine PCA 0,5 mg The patient controlled analgesia device give 0,5 mg morphine for each demand of the patient.	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.; Other Names: Morphine sulphate 0,5 mg
Placebo Comparator: Placebo 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; the PCA will contain placebo; Other Names: serum physiologic, dexketoprofen trometamol, paracetamol

Outcome Measures

Primary Outcome Measures

1. Integrated pulmonary index system [24 hour postoperatively]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria: , brain tumors, elective supratentorial craniotomies,

• Conscious patients

• Elective supratentorial craniotomies

• ASA I-III

Exclusion Criteria:

• Unconscious postoperatively

• Chronic pain

• Opioid, dexketoprofen or paracetamol allergy

• Delirium

• Renal insufficiency

• Alcohol, opioid dependency

• Transsphenoidal pituitary surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University Cerrahpasa Medical School	Istanbul		Turkey	34304

Sponsors and Collaborators

• Istanbul University

Investigators

• Study Director: Yusuf Tunali, Professor, Cerrahpasa Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Eren Fatma Akcil, SPECİALİST ANESTHESİOLOGİST, Istanbul University
• ClinicalTrials.gov Identifier: NCT04313374
• Other Study ID Numbers: Cerrahpasa Neuroanaesthesia
• First Posted: Mar 18, 2020
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Eren Fatma Akcil, SPECİALİST ANESTHESİOLOGİST, Istanbul University: Integrated pulmonary index, opioid side effects
• Additional relevant MeSH terms: Brain Neoplasms; Dexketoprofen trometamol; Morphine

Study Results

No Results Posted as of Mar 18, 2020