Magnesium and Ketamine in Postoperative Analgesia

Postoperative Analgesia Clinical Trial

Official title:

Evaluation of the Effect of Adding Magnesium Sulfate Infusion to Ketamine Infusion on Improvement of the Analgesic Efficacy in Cancer Breast Surgeries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111848
• Other study ID #: AP1904-50102
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Drug:
• Ketamine
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
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.

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the total amount of morphine required during the first postoperative 24 hours	After transferring to post-anaesthesia care unit (PACU), the IV route of each patient will be connected to a PCA device containing morphine solution (1mg/ml). This PCA device will be set to deliver a demand dose of 1ml with a lockout interval of 15 minutes and without a continuous background infusion.; The primary outcome in this study will be assessed in the form of the total amount of morphine required during the first postoperative 24 hours.	the first postoperative 24 hours
Secondary	the total amount of intraoperative fentanyl consumption	the total amount of intraoperative fentanyl required to maintain values of mean blood pressure within 20% of their baseline values	during anaesthesia (intraoperative)
Secondary	(Visual Analogue scale) VAS scores	(VAS) scores during rest and with shoulder movement at 0, 4, 8, 12and 24 post-operative hours	the first postoperative 24 hours
Secondary	Douleur Neuropathique 4 (DN4	Chronic post-operative pain will be evaluated in all patients during their outpatient follow-up visit after 3 months. Patients with score of = 4 in the Douleur Neuropathique 4 (DN4) questionnaire will indicate the incidence of neuropathic pain.	3 months after surgery