Brain TumorsPhase 4NCT04313374
Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia
A Phase 4 study testing Morphine PCA 1 mg and Morphine PCA 0,5 mg in people with Brain Tumors, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumors
- What is being tested?
- Morphine PCA 1 mg and Morphine PCA 0,5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2016to 1 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unconscious postoperatively
- Chronic pain
- Opioid, dexketoprofen or paracetamol allergy
- Delirium
- Renal insufficiency
- Alcohol, opioid dependency
- Transsphenoidal pituitary surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Medical School
Istanbul, 34304
About this study
Official title: Effective and Safe Morphine Dose for Patient Controlled Anesthesia in Supratentorial Craniotomies
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.
Read the 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.
- Conditions
- Brain Tumors
- Being tested
- Morphine PCA 1 mg, Morphine PCA 0,5 mg, Placebo
- Keywords
- Integrated pulmonary index, opioid side effects
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine PCA 1 mgDrug
Also called Morphine sulphate 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.
Morphine PCA 0,5 mgDrug
Also called Morphine sulphate 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.
PlaceboDrug
Also called serum physiologic, dexketoprofen trometamol, paracetamol
the PCA will contain placebo
| Study group | Role | What they receive |
|---|---|---|
| Morphine PCA 1 mg | Active comparator | The patient controlled analgesia device give 1mg morphine for each demand of the patient. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Aug 2016
- Primary completion1 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Fatma Akcil, Istanbul University
- Investigators
- Yusuf Tunali, Professor, Study director, Cerrahpasa Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313374
- Sponsor's protocol ID
- Cerrahpasa Neuroanaesthesia
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.3171/jns.2007.106.2.210.
PubMed 17410701Thibault 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.
PubMed 17602040Mordhorst 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.
PubMed 20479664
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective and Safe Morphine Dose for Patient Controlled Anesthesia in Supratentorial Craniotomies
- ClinicalTrials.gov ID
- NCT04313374
- Acronym / sponsor ID
- Cerrahpasa Neuroanaesthesia
- Conditions
- Brain Tumors
- Keywords
- Integrated pulmonary index, opioid side effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Morphine PCA 1 mg | Active comparator | Drug: Morphine PCA 1 mgThe patient controlled analgesia device give 1mg morphine for each demand of the patient. |
| Morphine PCA 0,5 mg | Active comparator | Drug: Morphine PCA 0,5 mgThe patient controlled analgesia device give 0,5 mg morphine for each demand of the patient. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Unconscious postoperatively
- Chronic pain
- Opioid, dexketoprofen or paracetamol allergy
- Delirium
- Renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine PCA 1 mgAlso: Morphine sulphate 1 mgPCA 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 PCA 1 mg |
| Morphine PCA 0,5 mgAlso: Morphine sulphate 0,5 mgPCA 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 PCA 0,5 mg |
| PlaceboAlso: serum physiologic, dexketoprofen trometamol, paracetamolthe PCA will contain placebo | Drug | Placebo |
Primary outcome
Integrated pulmonary index system
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 17410701Gottschalk 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.
- Background: PubMed 17602040Thibault 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.
- Background: PubMed 20479664Mordhorst 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Tunali, Professor study director
Cerrahpasa Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine PCA 1 mg and Morphine PCA 0,5 mg in people with Brain Tumors, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated pulmonary index system (time frame: 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313374, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.