Enhanced Recovery After Spinal Surgery Protocol Versus Conventional Care in Non Insulin Diabetic Patients ( ERAS )
Condition: ERAS; Surgery; Non Insulin Dependent Diabetes Mellitus; Lumbar Spine Disease
MeSH terms: Spinal Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      enhanced recovery after spinal surgery protocol (ERAS) versus conventional care in non
      insulin diabetic patients. Our hypothesis is that non-insulin dependent diabetic patients who
      will undergo lumbar decompression surgery following ERAS care may have higher quality of
      recovery after surgery, lower postoperative pain scores, decreased opioid consumption,
      reduced Length of stay and reduce perioperative stress compared to conventional general
      anaesthesia.
    

Detailed description: 
      72 patients of American Society of Anaesthesiology (ASA) physical status II or III, of both
      sexes, aged (30-65) years admitted to department of neurosurgery, Alexandria Main University
      Hospital and scheduled for elective lumbar decompression surgeries under the effect of
      general anaesthesia.

      All patients will be randomized 1:1 using a sealed envelope method to receive their
      perioperative care under our ERAS protocol versus conventional care. The envelope will be
      opened by an observer not involved in the study. Patients will be divided into two equal
      groups.

      Group (E): ERAS group: 36 non-insulin dependent diabetic patients will undergo lumbar
      decompression surgery following ERAS protocol.

      Group (C): Conventional group: 36 non-insulin dependent diabetic patients will undergo lumbar
      decompression surgery under conventional perioperative care.

      During preoperative visit, evaluation of patients will be carried out through proper history
      taking, clinical examination and routine laboratory investigations including complete blood
      picture, coagulation profile, blood urea, serum creatinine, serum electrolytes, fasting blood
      glucose, glycosylated haemoglobin (HBA1C), liver function tests and any other investigation
      needed.

      Pre-anaesthetic preparation and premedication:

      In both groups:

      Every patient will be informed about the ERAS protocol and the procedure of US guided erector
      spinae plane block.

      Informed written consent, from all individual participants who will be included in this study
      or their legal representatives will be taken during preoperative visit.

      The patient should be trained during preoperative visit on a visual analogue scale (VAS),
      with 0 corresponding to no pain and 10 to the worst pain imaginable.

      Thrombotic prophylaxis (enoxaparin 40 mg) will be started 12 hours before surgery.

      Oral hypoglycemic control drugs will be discontinued after the last meal. In ERAS group,
      patients will receive solid foods until 6 hours before surgery and clear fluids until 4 hours
      prior. A 400 ml of clear carbohydrate-rich beverage (12.5g/100ml) will be supplied before the
      day of surgery, to be consumed 4 hours before the scheduled time of surgery, while in non-
      ERAS group, patients will fast for 8 hours.(25) In both groups, Antibiotic prophylaxis
      (ceftriaxone 2 g intravenously) will be given 1 hour before surgical incision.

      In ERAS group, Oral pre-emptive analgesia will be provided in the holding area on the day of
      surgery, and will include acetaminophen (1000 mg), gabapentin (300 mg), provided there is no
      contraindications, while in non- ERAS group, no analgesia will be given.

      Finger stick glucose monitoring will be applied every 2 hours and rapid acting subcutaneous
      insulin will be given if blood glucose is > 180 mg/dl.

      On arrival to operative theatre, before the induction of anaesthesia, standard monitoring
      will be established using multichannel monitor (Carescape Monitor B650, General electric (GE)
      Healthcare Finland) to monitor the following in both groups:

      Electrocardiogram (ECG) for heart rate and rhythm. (Beats/min). Non-invasive measurement of
      arterial blood pressure. (Mean blood pressure in mmHg).

      Pulse oxygen saturation. (SpO2%). End tidal carbon dioxide ( CO2) tension (in mmHg). Entropy
      Neuromuscular transmission (TOF; transmission with four stimuli) Nasopharyngeal core
      temperature In ERAS group, the non-invasive cardiac output monitoring device (ICON, Osypka
      Medical, Berlin, Germany) will be attached to the patient by four electrodes. Two electrodes
      will be on the right side of the neck, the two other electrodes on the left side of the chest
      opposite to the xiphoid process at the mid axillary line.

      Anaesthesia:

      After preoxygenation for 3 minutes, anaesthesia will be induced in both groups with propofol
      0.5-2mg/kg until loss of verbal response, fentanyl 2µg/kg and atracurium 0.5 mg/kg
      intravenously. Anaesthesia will be maintained by isoflurane with 50% oxygen in air (1.2-1.5
      %) to maintain entropy between 40-60. Mechanical ventilation will be performed with a
      constant tidal volume of 8 ml/ kg and a respiratory rate of 10 to 12 cycles/min to maintain
      the end-tidal carbon dioxide tension between 35 and 40 mmHg and an oxygen saturation of ≥ 98
      per cent with 50 percent oxygen in air. Incremental doses of atracurium will be given
      according to nerve stimulator.

      In both groups, signs of insufficient analgesia (eg, tachycardia over 20% of the preoperative
      value occur during anaesthesia) or somatic response (eg, movement ,tearing ,or sweating),
      will be treated with additional boluses of fentanyl 0.5 mcg/kg intraoperatively as needed.
      Strategies to prevent hypothermia include the use of warmed infusion liquids, and forced
      air-warming blankets will be done to avoid intraoperative hypothermia.

      In ERAS group, dual antiemetic prophylactic therapy (metoclopramide 10 mg iv. and
      dexamethasone 8mg iv) will be administered intravenously immediately after induction. Also,
      intravenous infusion of tranexamic acid 10 mg/kg(27) will be given in this group.

      In ERAS group, after turning the patient into prone position, US guided erector spinae plane
      (ESP) block will be given.

      In both groups: Intraoperative blood glucose level will be maintained intraoperatively
      between 140 and 180 mg/dl. If a patient has a blood glucose level greater than or equal to
      180, an IV insulin drip will be initiated. Starting dose of insulin drip (units/hour) can be
      calculated with blood glucose/100 and titrated according to the following regimen by checking
      the blood glucose level every hour.

      At the end of the surgery, patient will be turned to supine position then anaesthesia will be
      discontinued and 100% oxygen will be administered then the oral secretions will be aspirated.
      The residual neuromuscular relaxation will be reversed using neostigmine 40 ug/kg and
      atropine 20 ug/kg slowly by the intravenous route. Extubation will be performed awake after
      the return of protective airway reflexes.

      Upon admission to the post-anesthesia care unit (PACU), all patients will be observed
      continuously for at least 30 min by observers blinded to study groups.

      All the procedures will be performed by the same three surgeons, all with a clinical
      experience of more than 5 years using the same surgical technique for each type of surgery.
      Due to the requirement for active patient participation, it will not possible to perform the
      study with blinded participants and care providers. Only those who will collect and assess
      the postoperative outcomes in PACU and the ward will be blinded to the patient group
      assignment and to the nature of the study.

      Postoperative Management:

      In ERAS group, immediate postoperative management will include cessation of intravenous fluid
      administration, oral intake, and mobilization within 2 hours of PACU arrival.

      In ERAS group, target postoperative glycemic range will be between 140 and 180mg/dl. The
      insulin infusion will be continued postoperatively until oral intake will be established,
      after which the preoperative diabetes treatment will be resumed. The first dose of the oral
      hypoglycemic drugs will be given 30-60 min before disconnecting the infusion.

      In both groups, intravenous paracetamol 1 g/6 hours (Perfalgan® 100 ml vial The Union of
      applied scientific pharmacology (UPSA) France) and intravenous ketorolac loading 30 mg then
      15mg/8 hours regularly will be given for postoperative pain relief. Nalbuphine 0.15 mg/kg IV
      will be given as postoperative rescue analgesia if VAS was ≥ 4. The incidence of
      postoperative nausea and vomiting (PONV) will be assessed by a nurse for the first 24 hrs and
      only 2 possible answers will be accepted (yes or no).

      The volume status will be assessed by the blood pressure, heart rate, urine output and mental
      status of patients. Patients will be discharged from the PACU according to modified Aldrete
      score (if the score is ≥ 9, the patient can be discharged).
    

Intervention name(s): ERAS protocol
Intervention type(s): Other
Intervention description(s): to compare between Enhanced Recovery After Surgery (ERAS) protocol and conventional care in non-insulin dependent diabetic patients undergoing lumbar spine surgery.
Other intervention name(s): enhanced recovery after surgery protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research