- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04111848
Magnesium and Ketamine in Postoperative Analgesia
Evaluation of the Effect of Adding Magnesium Sulfate Infusion to Ketamine Infusion on Improvement of the Analgesic Efficacy in Cancer Breast Surgeries.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- National Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ketamine group : group (k)
-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
|
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. |
Experimental: ketamine and magnesium group: group (KM)
- 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): 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the total amount of morphine required during the first postoperative 24 hours
Time Frame: 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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the total amount of intraoperative fentanyl consumption
Time Frame: during anaesthesia (intraoperative)
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the total amount of intraoperative fentanyl required to maintain values of mean blood pressure within 20% of their baseline values
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during anaesthesia (intraoperative)
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(Visual Analogue scale) VAS scores
Time Frame: the first postoperative 24 hours
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(VAS) scores during rest and with shoulder movement at 0, 4, 8, 12and 24 post-operative hours
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the first postoperative 24 hours
|
Douleur Neuropathique 4 (DN4
Time Frame: 3 months after surgery
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Hassan, MD, Ass Prof- Anesthesia Dept- National Cancer Institute - Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Perceptual Disorders
- Agnosia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- AP1904-50102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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