The Effect of Opioid Free Anesthesia in Bariatric Surgeries
Condition: Adverse Effect of Drugs and Medicaments in Therapeutic Use; Adverse Effects in the Therapeutic Use of Anaesthetics
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective randomized controlled study that will be carried out on morbid obese
      patients admitted to Tanta University hospitals for laparoscopic bariatric surgeries. The
      patients will be randomly assigned into;- Control group:- Anesthesia will be induced by
      fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation.
      Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain
      entropy 40-60.

      Opioid free anesthesia group;- Anesthesia will be induced by propofol 2 mg/kg, rocuronium 1
      mg/kg to facilitate tracheal intubation. After endotracheal intubation, and a combination of
      dexmedetomidine and ketamine infusion. Anesthesia will be maintained by sevoflurane 2% in a
      mixture of oxygen: Air 1: 1 and continuing the infusion of dexmedetomidine and ketamine o
      maintain entropy 40-60.
    

Detailed description: 
      This prospective randomized controlled study will be carried out on patients who will be
      presented for laparoscopic bariatric surgery in the general surgery department in Tanta
      university hospitals over six-month duration that will start immediately after obtaining
      ethical committee approval and clinical trial registration. 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:

      Morbid obese patients with BMI 40-50 kg/m2 aged more than 21 years and American Society of
      Anesthesiologists Class III presented for laparoscopic sleeve gastrectomy or gastric bypass.

      Exclusion criteria:

        -  Patients refused to participate.

        -  Patients with known or suspected or known allergy to the used medication.

        -  Patients with moderate to severe obstructive sleep apnea

        -  Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.

        -  Patients receiving opioids preoperatively

        -  Uncooperative patients

        -  Patients received preoperative gabapentoids.

      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.

      The patients will be randomly distributed into two equal groups by the aid of
      computer-generated software of randomization: - ▪ Control group (30 patients): Anesthesia
      will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate
      tracheal intubation. After endotracheal intubation, Anesthesia will be maintained by
      sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The patients in
      this group will be connected to a syringe pump before induction of anesthesia that was
      prepared by anesthesia resident not participating in the study and contain normal saline and
      adjusted at a rate of 1 ml/kg/hr till the end of the surgery.

      ▪ Opioid free anesthesia group (30 patients): A syringe 50 ml was prepared by anesthesia
      resident not participating in the study and contain 100 ug of dexmedetomidine (2 ug/ml) and
      25 mg ketamine 90.5 mg/ml) and 200 mg lidocaine (4 mg/ml). The syringe will be connected to
      the patients before induction of anesthesia at a rate of 0.1 ml/kg/hr according to the ideal
      body weight. Anesthesia will be induced by propofol 2 mg/kg, and rocuronium 1 mg/kg to
      facilitate tracheal intubation. Anesthesia will be maintained by sevoflurane 2% in a mixture
      of oxygen: Air 1: 1 to maintain entropy 40-60. The syringe infusion will be continued till
      the end of peritoneal manipulation. Patients in this group will receive magnesium sulphate
      preload at a dose of 40 mg/kg ideal body weight followed by maintenance infusion of 10
      mg/kg/hr.

      In both groups, routine anti-emetic prophylaxis will be administrated composed of ondansetron
      4 mg and dexamethasone 8 mg before the surgery. Additional analgesia will be provided using 1
      gm of paracetamol together with intraperitoneal local anesthetics and wound infiltration.

      All the patients will be connected to the bispectral index monitor with maintaining its value
      40-60. Increase in n bispectral index value above 60 will be managed by additional dose of
      fentanyl 0.5 ug/kg IBW and increasing the concentration of sevoflurane by 0.2% till the value
      decreased below 60.

      At the end of the surgery, the inhalational anesthesia will be switched off with reversal of
      muscle relaxation using neostigmine and atropine with full awake extubation of the patient.
      The patients will be transported to the recovery room for adequate postoperative monitoring
      and management.

      Measurements:

        1. Patient age, weight, height.

        2. The total dose consumption of fentanyl consumed intraopeartively.

        3. The total volume consumed of sevoflureane intraoperatively (ml/hr).

        4. 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 2mg morphine i.v that may be repeated.

        5. The time for the first request of morphine rescue analgesia

        6. The total dose of morphine consumed in the first 24 h after surgery

        7. The recovery profile of the patient.

        8. Patients satisfaction.
    

Intervention name(s): Fentanyl; Dexmedetomidine Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia will be induced by fentanyl, propofol, and rocuronium with maintenance of anesthesia using sevoflurane.; No opioid will be used in induction of anesthesia. A combination of dexmedetomidine and ketamine will be infused. Sevoflurane will be used for maintenance of anesthesia.
Other intervention name(s): Opioid based Anesthesia; Opioid sparing
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Ketamine; Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dexmedetomidine; Ketamine; Fentanyl; Bariatric surgeries