Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia
Condition: Brain Tumors
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Morphine PCA 1 mg; Morphine PCA 0,5 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; the PCA will contain placebo
Other intervention name(s): Morphine sulphate 1 mg; Morphine sulphate 0,5 mg; serum physiologic, dexketoprofen trometamol, paracetamol
Intervention MeSH terms: Dexketoprofen trometamol; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Integrated pulmonary index, opioid side effects