Clinical trial NCT04111848: Magnesium and Ketamine in Postoperative Analgesia
Official title: Evaluation of the Effect of Adding Magnesium Sulfate Infusion to Ketamine Infusion on Improvement of the Analgesic Efficacy in Cancer Breast Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Analgesia
Keywords: Magnisum sulfate
Ketamine
Analgesia
Breast Cancer Surgeries
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the total amount of morphine required during the first postoperative 24 hours
timeFrame: the first postoperative 24 hours
Secondary outcomes:
measure: the total amount of intraoperative fentanyl consumption
timeFrame: during anaesthesia (intraoperative)
measure: (Visual Analogue scale) VAS scores
timeFrame: the first postoperative 24 hours
measure: Douleur Neuropathique 4 (DN4
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: Ass Prof- Anesthesia Dept- National Cancer Institute - Cairo University
name: Mohamed Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: