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Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia

Primary Purpose

Brain Tumors

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Morphine PCA 1 mg
Morphine PCA 0,5 mg
Placebo
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumors focused on measuring Integrated pulmonary index, opioid side effects

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University Cerrahpasa Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Morphine PCA 1 mg

Morphine PCA 0,5 mg

Placebo

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2018
Last Updated
March 17, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04313374
Brief Title
Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia
Official Title
Effective and Safe Morphine Dose for Patient Controlled Anesthesia in Supratentorial Craniotomies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
Integrated pulmonary index, opioid side effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment
Masking
ParticipantInvestigator
Masking Description
the patient, the investigator of the study will be blinded
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine PCA 1 mg
Arm Type
Active Comparator
Arm Description
The patient controlled analgesia device give 1mg morphine for each demand of the patient.
Arm Title
Morphine PCA 0,5 mg
Arm Type
Active Comparator
Arm Description
The patient controlled analgesia device give 0,5 mg morphine for each demand of the patient.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine PCA 1 mg
Other Intervention Name(s)
Morphine sulphate 1 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine PCA 0,5 mg
Other Intervention Name(s)
Morphine sulphate 0,5 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
serum physiologic, dexketoprofen trometamol, paracetamol
Intervention Description
the PCA will contain placebo
Primary Outcome Measure Information:
Title
Integrated pulmonary index system
Description
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.
Time Frame
24 hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusuf Tunali, Professor
Organizational Affiliation
Cerrahpasa Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Cerrahpasa Medical School
City
Istanbul
ZIP/Postal Code
34304
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17410701
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. doi: 10.3171/jns.2007.106.2.210.
Results Reference
background
PubMed Identifier
17602040
Citation
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.
Results Reference
background
PubMed Identifier
20479664
Citation
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.
Results Reference
background

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Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia

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