Magnesium and Ketamine in Postoperative Analgesia

NCT04111848 | Completed Phase 4

• 1 other identifier: AP1904-50102
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Analgesia

Keywords

Magnisum sulfate; Ketamine; Analgesia; Breast Cancer Surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the total amount of intraoperative fentanyl consumption

  during anaesthesia (intraoperative)

• (Visual Analogue scale) VAS scores

  the first postoperative 24 hours

• Douleur Neuropathique 4 (DN4

  3 months after surgery

Study Arms (2)

ketamine group : group (k)

EXPERIMENTAL

-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

Drug: Ketamine

ketamine and magnesium group: group (KM)

EXPERIMENTAL

\- 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.

Drug: ketamine and magnesium

Interventions

Ketamine DRUG

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 group : group (k)

ketamine and magnesium DRUG

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.

ketamine and magnesium group: group (KM)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

Related Publications (1)

• Hassan ME, Mahran E. Effect of magnesium sulfate with ketamine infusions on intraoperative and postoperative analgesia in cancer breast surgeries: a randomized double-blind trial. Braz J Anesthesiol. 2023 Mar-Apr;73(2):165-170. doi: 10.1016/j.bjane.2021.07.015. Epub 2021 Jul 29.

  PMID: 34332956 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Magnesium

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Mohamed Hassan, MD

  Ass Prof- Anesthesia Dept- National Cancer Institute - Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study medications were prepared by a pharmacist who was not involved in the patient management or the data collection. Both the patients and the stuff involved in their management were unaware of the group assignment. Equal rates of the drug infusion and equal volumes of the administered drugs were applied to all patients to ensure double blinding of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 1, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)