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Completed

NCT Number: NCT04111848

Magnesium and Ketamine in Postoperative Analgesia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

National Cancer Institute

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. the total amount of intraoperative fentanyl consumption

    Time frame: during anaesthesia (intraoperative)

    the total amount of intraoperative fentanyl required to maintain values of mean blood pressure within 20% of their baseline values

  2. (Visual Analogue scale) VAS scores

    Time frame: the first postoperative 24 hours

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

  3. Douleur Neuropathique 4 (DN4

    Time frame: 3 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2019
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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