Dexmedetomidine-Ketamine Infusion in Breast Surgeries
Condition: Total Intravenous Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      -  This is a prospective randomized double blind controlled study.

        -  Female patients undergoing radical mastectomy will be included in this stydy where they
           will be randomly allocated into;- Control group in which patients will receive
           continuous infusion of normal saline.

      Dexmedetomidine-Ketamine group which patients will receive continuous infusion of ketamine
      and dexmedetomidine.

      The intraoperative and postoperative opioid consumption will be measured. Also, the
      postoperative pain score and the incidence of chronic pain will be assessed.
    

Detailed description: 
      This prospective randomized controlled study will be carried out on 70 female patients who
      will be presented for radical mastectomy in the general surgery department in Tanta
      university hospitals over three month duration and 6 months follow up that starts immediately
      after obtaining ethical committee approval, an informed written consent will be obtained from
      all the participants, all patients data will be confidential and will be used for the current
      study only.

      -Inclusion criteria: Female patients aged 50-70 years, ASA class I-II, and presented for
      elective radical mastectomy.

      - Exclusion criteria: Patients refused to participate. Patients with known or suspected or
      known allergy to the used medication. Patients with preoperative chronic pain, Patients
      received preoperative opioids or gabapentoids. Patients with major cardiac, renal,
      respiratory, or hepatic disease. Uncooperative patients. Obese patients with BMI >36

      Anesthetic technique Once the patients will arrive to the operating room, intravascular
      access will be established, fluid preload will be started, and basic monitor will be
      attached. An assistant anesthetist will help in preparation of a 50 ml syringe connected to a
      syringe pump that will contain normal saline or a mixture of 100 ug dexmedetomidine and 50 mg
      ketamine.

      Anesthesia will be induced by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15
      mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be
      connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 32-36
      mmhg. Anesthesia will be maintained by isoflurane 1% MAC in mixture of oxygen:air 1:1 with
      the use of low flow (1 ml/min). The patients will be randomly allocated into two equal groups
      by the aid of computer-generated software of randomization; -

      • Control group (35 patients): The patients in this group will be connected to the syringe
      pump that contain normal saline with starting infusion at a rate of 0.1 ml/kg/hr till the end
      of the surgery.

      • Dexmedetomidine-Ketamine group (30 patients): The patients in this group will be connected
      to the syringe pump that contain mixture of dexmedetomidine and ketamine with starting
      infusion at a rate of 0.1 ml/kg/hr till the end of the surgery. The solution will contain 2
      ug dexmedetomidine/ml and 1 mg ketamine/ml.

      All the patients will be connected to a bispectral index monitor with maintaining its value
      ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of
      fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the
      isoflurane 0.2 % MAC till it decreased below 60.

      At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle
      relaxation, and awake tracheal extubation will be done with transporting the patients to the
      PACU for postoperative follow up and monitoring.

      - Measurements:

        1. Patient age, weight, height.

        2. Morphine consumption in the first 24 h postoperatively.

        3. The total dose consumption of fentanyl consumed intraopeartively.

        4. The total volume consumed of isoflurane intraoperatively (ml/hr).

        5. The postoperative Visual Analogue Score (VAS): It will be measured every 2 hours till 6
           h, then every 4 h till 24 h. In case of increase the VAS more than 3, a rescue analgesia
           will be administrated in the form of 3 mg morphine i.v that may be repeated.

        6. The time for the first request of morphine rescue analgesia

        7. The incidence of chronic pain (Follow up of the patients will be carried out in the pain
           clinic after discharge from hospital every 2 weeks for a period of 6 months for
           assessment of the incidence of postoperative chronic pain.
    

Intervention name(s): Placebos; Dexmedetomidine +Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): The patients in this group will be connected to the syringe pump that contain normal saline with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery.; The patients in this group will be connected to the syringe pump that contain mixture of dexmedetomidine and ketamine with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery. The solution will contain 2 ug dexmedetomidine/ml and 1 mg ketamine/ml.
Other intervention name(s): Normal saline infusion; Intravenous anesthesia
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dexmedetomidine; Ketamine; Radical Mastectomy; Chronic pain