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Magnesium and Ketamine in Postoperative Analgesia

Primary Purpose

Postoperative Analgesia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
ketamine and magnesium
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Analgesia focused on measuring Magnisum sulfate, Ketamine, Analgesia, Breast Cancer Surgeries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ketamine group : group (k)

ketamine and magnesium group: group (KM)

Arm 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

- 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
(Visual Analogue scale) VAS scores
(VAS) scores during rest and with shoulder movement at 0, 4, 8, 12and 24 post-operative hours
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.

Full Information

First Posted
September 30, 2019
Last Updated
February 28, 2021
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04111848
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia
Keywords
Magnisum sulfate, Ketamine, Analgesia, Breast Cancer Surgeries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketamine group : group (k)
Arm Type
Experimental
Arm 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
Arm Title
ketamine and magnesium group: group (KM)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ketamine and magnesium
Intervention 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.
Primary Outcome Measure Information:
Title
the total amount of morphine required during the first postoperative 24 hours
Description
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.
Time Frame
the first postoperative 24 hours
Secondary Outcome Measure Information:
Title
the total amount of intraoperative fentanyl consumption
Description
the total amount of intraoperative fentanyl required to maintain values of mean blood pressure within 20% of their baseline values
Time Frame
during anaesthesia (intraoperative)
Title
(Visual Analogue scale) VAS scores
Description
(VAS) scores during rest and with shoulder movement at 0, 4, 8, 12and 24 post-operative hours
Time Frame
the first postoperative 24 hours
Title
Douleur Neuropathique 4 (DN4
Description
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.
Time Frame
3 months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Hassan, MD
Organizational Affiliation
Ass Prof- Anesthesia Dept- National Cancer Institute - Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Magnesium and Ketamine in Postoperative Analgesia

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