drugset / Trial / NCT04111848

Magnesium and Ketamine in Postoperative Analgesia

NCT04111848

Phase 4 Completed 90 enrolled National Cancer Institute, Egypt
RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2019-11-01
Primary completion
2020-11-01
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified 8 mg/kg
Background Ketamine Small molecule 0.12 mg/kg

Indications

No indication recorded.