Magnesium and Ketamine in Postoperative Analgesia

National Cancer Institute, Egypt

Status and phase: Completed; Phase 4

Conditions: Postoperative Analgesia

Treatments: Drug: Ketamine; Drug: ketamine and magnesium

Study type: Interventional

Funder types: Other

Identifiers

NCT04111848

AP1904-50102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with class II physical status (American Society of Anaesthesiologists) ,
• Age between 18-65 years,
• Scheduled for breast cancer surgery (e.g. modified radical mastectomy and conservative mastectomy)

Exclusion criteria

• Patient refusal,
• Cardiac dysfunction (ejection fraction <45%),
• Diabetic patients
• Patients with uncontrolled hypertension
• Patients have any degree of heart block
• Patients have renal impairment (creatinine > 2 mg/dl),
• Patients have hepatic dysfunction (transaminases > 2 times normal),
• Patients with preexisting neurological or psychiatric disease,
• Patients who are allergic to one of the study drugs,
• Patients with communication difficulties,
• Inability to use the patient controlled analgesia (PCA) device,
• Female patients who are pregnant
• Patients who use preoperative calcium channel blockers or narcotic drugs.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

ketamine group : group (k)

Experimental group

Description:

-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

Treatment:

Drug: Ketamine

ketamine and magnesium group: group (KM)

Experimental group

Description:

- 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.

Treatment:

Drug: ketamine and magnesium