Magnesium and Ketamine in Postoperative Analgesia
Condition: Postoperative Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      90 female patients scheduled for cancer breast surgeries will be assigned to 2 groups, each
      of 45. Group (K) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia,
      followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. Group
      (KM) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30
      minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added
      to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. The same
      anaesthetic regimen will be applied to all patients. Total intraoperative fentanyl required
      to maintain mean blood pressure within 20% of its baseline will be recorded. After surgery,
      all patients will be connected to PCA device containing morphine solution, the amount of
      morphine consumed during the first 24 hours will be recorded. In the follow-up visits after 3
      months, all patients will be assessed for neuropathic pain by DN4 questionnaire.
    

Detailed description: 
      90 female patients aged between 18 and 65 years, scheduled for cancer breast surgeries will
      be assigned to 2 groups, each of 45. Group (K) will receive a bolus of 0.5 mg/kg ketamine
      with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till
      24 hours after surgery. Group (KM) will receive a bolus of 0.5 mg/kg ketamine added to
      50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by
      ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24
      hours after surgery. The same anaesthetic regimen will be applied to all patients. Total
      intraoperative fentanyl required to maintain mean blood pressure within 20% of its baseline
      will be recorded. After surgery, all patients will be connected to PCA device containing
      morphine solution, the amount of morphine consumed during the first 24 hours will be
      recorded. In the follow-up visits after 3 months, all patients will be assessed for
      neuropathic pain by DN4 questionnaire.
    

Intervention name(s): Ketamine; ketamine and magnesium
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be assigned into 2 groups (each of 45):
Ketamine group (group K): will receive a bolus of 0.5 mg/kg ketamine during induction of anaesthesia diluted in 100 ml normal saline, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. The infusion pump concentration will be 0.6mg/ml and the rate of infusion will be 0.2 ml/kg/hour.; Ketamine and magnesium group (group KM): will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate diluted in 100 ml normal saline over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. Each ml of the administered infusion will contain 0.6mg ketamine and 40mg magnesium and the rate of infusion will be 0.2 ml/kg/hour.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 90 female patients scheduled for cancer breast surgeries will be assigned to 2 groups, each of 45. Group (K) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. Group (KM) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Magnisum sulfate; Ketamine; Analgesia; Breast Cancer Surgeries