Propofol or Sevoflurane Anesthesia in Egyptian Patients
Condition: Anesthesia
Study type: Interventional

Summary: 
      The proposed research in this application will investigate postoperative cognitive function,
      pain index, inflammatory response, and oxidative stress effects of propofol versus
      sevoflurane anesthetic drugs in patients undergoing elective, major, non-cardiac operations
      under general anesthesia to investigate which of them will significantly maintain better
      cognitive function, decrease the pain index, inflammatory reaction, and oxidative stress,
      improve outcome, shorten the postoperative recovery time and reduce length of hospital stay,
      and consequently the cost of hospital stay.
    

Detailed description: 
      1. Ethical committee approval will be obtained from Ethics committee of Faculty of
           Pharmacy, Damanhour University.

        2. Ethical committee approval will be obtained from Ethics committee of General
           Organization for Teaching Hospitals and Institutes.

        3. About 44 patients who are candidate for elective, major, non-cardiac operations under
           general anesthesia with either propofol infusion or sevoflurane inhalation, will be
           recruited from Damanhour Teaching Hospital, General Organization for Teaching Hospitals
           and Institutes.

        4. All participants should agree to take part in this clinical study and will provide
           informed consent.

        5. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2)
           will be collected.

        6. ASA physical status and type of operation will be recorded.

        7. Venous blood samples (5 ml will be collected by a sterile syringe then placed in a
           suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C
           until the analysis) before, and 1 hour after operation for evaluating cognitive function
           by analyses of Neuron Specific Enolase (NSE, µg/L) and (S100-β protein, pg/mL) and for
           determining inflammatory response by measuring Matrix Metallo-Proteinase-9 (MMP-9,
           ng/mL), and effect of these anesthetic drugs on oxidative stress by measuring Super
           Oxide Dismutase (SOD, U/L).

        8. Cognitive function scale: Mini-Mental State Examination (MMSE scale, if decreased more
           than 2 points from before operation indicate that the cognitive function of patients are
           declined) and pain index: Numerical Pain Rating scale (NPRS) (a scale from 0-10, where 0
           = no pain and 10 = maximum worst pain) will be performed on all patients before, 1 hour,
           and 24 hours after operation.

        9. Heart rate (beat/min), oxygen saturation (%), and non-invasive blood pressure (mmHg)
           (systolic, diastolic, mean) will be recorded before and after operation.

      10 Anesthesia duration (min) (the time from induction of anesthesia till stoppage of
      anesthesia) and operative duration (min) (the time from skin incision till skin closure) will
      be recorded.

      11. Time to emerge from anesthesia (min) (the time from stopping the use of anesthetics to
      patients relatively clearly answering the doctor's questions) will be recorded.

      12. The incidence of any perioperative adverse effects will be recorded as; tachycardia,
      bradycardia, hypertension, hypotension, nausea, vomiting, hypoxia, and bleeding.

        -  Study design: This is a prospective, randomized (1:1), clinical trial, will be carried
           out on 44 patients who are candidate for elective, major, non-cardiac operations under
           general anesthesia.

        -  Patients will be randomly allocated into two equal groups (22 patients each); group (P)
           for propofol and group (S) for sevoflurane.

        -  The day before the operation, patients will be taught to measure postoperative pain
           based on the NPRS. Patients will be fasting for 6-8 h for a solid meal and 2 hours for
           clear fluid before the operation.

        -  On arrival to the operating room, a peripheral IV cannula will be secured and standard
           monitoring using an electrocardiogram, pulse oximetry, and non-invasive blood pressure
           will be applied.

        -  After preoxygenation with 100% oxygen for 3 min, general anesthesia will be induced
           using IV propofol (2 mg/kg) and IV fentanyl (1 μg/kg), and IV atracurium (0.5 mg/kg)
           will be given to facilitate tracheal intubation.

        -  Lungs will be ventilated using volume-controlled ventilation and the tidal volume and
           ventilation rate will be adjusted to maintain end-tidal carbon dioxide at 35-45 mmHg.

        -  Anesthesia will be maintained with either total intravenous anesthesia (TIVA) with
           propofol 6 mg/kg/h in group P or sevoflurane 1.0-1.5 minimum alveolar concentration
           (MAC) in group S.

        -  Continuous infusion of IV atracurium (0.3 mg/kg/h), and IV fentanyl (0.5 ug/kg/h) till
           the end of surgery.

        -  Thirty minutes before the end of the surgery all patients will be given IV paracetamol
           (15 mg/kg) for postoperative pain management.

        -  At the end of the surgery, either TIVA pump or the inhalational anesthetic vaporizer
           will be turned off and the muscle relaxant will be reversed by giving IV neostigmine
           (0.04 mg/kg) plus IV atropine (0.02 mg/kg).

        -  The patient will be extubated and transferred to the post-anesthesia care unit.

        -  All data and study outcomes will be recorded by a researcher who is blinded to group
           assignment.

        -  The primary outcome is the measure postoperative cognitive function by NSE.
    

Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Propofol (2 mg/kg) for induction of anesthesia , and ( 6 mg/kg/h) for maintenance of anesthesia; Sevoflurane 1.0-1.5 minimum alveolar concentration (MAC)
Other intervention name(s): Sevoflurane inhalant product
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized (1:1), double blind clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Effects.; Propofol; Sevoflurane; Anesthesia