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Enhanced Recovery After Spinal Surgery Protocol Versus Conventional Care in Non Insulin Diabetic Patients ( ERAS )

Primary Purpose

ERAS, Surgery, Non Insulin Dependent Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ERAS protocol
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for ERAS

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 30-65 years, both sexes
  • ASA physical status class II and III
  • 2-3 levels elective lumbar surgery.
  • Controlled non- insulin dependent diabetic patients (HbA1C ≤ 7% )

Exclusion Criteria:

  • Cervical and thoracic surgery
  • More than 3 levels surgery.
  • Cognitive impairment.
  • Infection, trauma, neoplasm.
  • Revision surgery.
  • Patients with BMI > 35 kg/m2, renal or cardiac and liver failure.
  • Patients with retinopathy or reduction of visual acuity.
  • Patients with known hypersensitivity or contraindication to medications.
  • Coagulopathy or uncontrolled Diabetes mellitus (DM) .
  • Patients receiving any analgesic medications within 24 h pre-operative or antiplatelet medication within the past 1 week.
  • Patients who had symptoms of nausea and vomiting or received an antiemetic within 24 h of surgery.
  • Random blood glucose more than 250 mg/dl just before shifting the patient from the ward to the operating room.

Sites / Locations

  • Faculty of Medicine, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group E: ERAS group

group C: conventional group

Arm Description

36 non-insulin dependent diabetic patients will undergo lumbar decompression surgery following ERAS protocol.

conventional perioperative care.

Outcomes

Primary Outcome Measures

Quality of recovery after surgery (QoR40)
40-item questionnaire that assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support, and pain and has a mean time to completion of 5 min.

Secondary Outcome Measures

heart rate
beats/minute
mean arterial blood pressure
mmHg
Postoperative pain score
Scale of 0-10, 0 being no pain, 10 being the worst pain possible
Perioperative nalbuphine requirements
measured in mg
postoperative hospital stay
measured in days after surgery
Time to first postoperative analgesic request
measured in minutes
Blood sugar level
mg/dl
Number of patients required rescue anti-emetic postoperatively
patients receive ondansetron
number of participants with Perioperative complications
vomiting, wound infection, urinary tract infection , deep vein thrombosis, haematoma
serum markers of stress response: C reactive protein ( CRP)
mg/dl
serum markers of stress response: interleukin 6 ( IL-6)
pg/ml

Full Information

First Posted
September 1, 2021
Last Updated
September 11, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05033899
Brief Title
Enhanced Recovery After Spinal Surgery Protocol Versus Conventional Care in Non Insulin Diabetic Patients ( ERAS )
Official Title
Enhanced Recovery After Spinal Surgery Protocol Versus Conventional Care in Non Insulin Diabetic Patients:A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERAS, Surgery, Non Insulin Dependent Diabetes Mellitus, Lumbar Spine Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
single
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group E: ERAS group
Arm Type
Experimental
Arm Description
36 non-insulin dependent diabetic patients will undergo lumbar decompression surgery following ERAS protocol.
Arm Title
group C: conventional group
Arm Type
No Intervention
Arm Description
conventional perioperative care.
Intervention Type
Other
Intervention Name(s)
ERAS protocol
Other Intervention Name(s)
enhanced recovery after surgery protocol
Intervention Description
to compare between Enhanced Recovery After Surgery (ERAS) protocol and conventional care in non-insulin dependent diabetic patients undergoing lumbar spine surgery.
Primary Outcome Measure Information:
Title
Quality of recovery after surgery (QoR40)
Description
40-item questionnaire that assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support, and pain and has a mean time to completion of 5 min.
Time Frame
postoperative day 2
Secondary Outcome Measure Information:
Title
heart rate
Description
beats/minute
Time Frame
surgery period
Title
mean arterial blood pressure
Description
mmHg
Time Frame
surgery period
Title
Postoperative pain score
Description
Scale of 0-10, 0 being no pain, 10 being the worst pain possible
Time Frame
8 hours postoperative
Title
Perioperative nalbuphine requirements
Description
measured in mg
Time Frame
24 hours postoperative
Title
postoperative hospital stay
Description
measured in days after surgery
Time Frame
postoperative day 5
Title
Time to first postoperative analgesic request
Description
measured in minutes
Time Frame
24 hours postoperative
Title
Blood sugar level
Description
mg/dl
Time Frame
time of admission to PACU
Title
Number of patients required rescue anti-emetic postoperatively
Description
patients receive ondansetron
Time Frame
24 hours postoperative
Title
number of participants with Perioperative complications
Description
vomiting, wound infection, urinary tract infection , deep vein thrombosis, haematoma
Time Frame
postoperative day 5
Title
serum markers of stress response: C reactive protein ( CRP)
Description
mg/dl
Time Frame
postoperative day 2
Title
serum markers of stress response: interleukin 6 ( IL-6)
Description
pg/ml
Time Frame
postoperative day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 30-65 years, both sexes ASA physical status class II and III 2-3 levels elective lumbar surgery. Controlled non- insulin dependent diabetic patients (HbA1C ≤ 7% ) Exclusion Criteria: Cervical and thoracic surgery More than 3 levels surgery. Cognitive impairment. Infection, trauma, neoplasm. Revision surgery. Patients with BMI > 35 kg/m2, renal or cardiac and liver failure. Patients with retinopathy or reduction of visual acuity. Patients with known hypersensitivity or contraindication to medications. Coagulopathy or uncontrolled Diabetes mellitus (DM) . Patients receiving any analgesic medications within 24 h pre-operative or antiplatelet medication within the past 1 week. Patients who had symptoms of nausea and vomiting or received an antiemetic within 24 h of surgery. Random blood glucose more than 250 mg/dl just before shifting the patient from the ward to the operating room.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ashraf arafat, MD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emad Abdelmoneim arida, MD
Organizational Affiliation
Alrxandria university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rania Aboelfetouh, MD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdulrahman Elhabashy, MD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
through clinical trials
IPD Sharing Time Frame
6 months up to 1 year
IPD Sharing Access Criteria
ERAS, lumbar spine surgery, non insulin diabetic patients, quality of recovery
Citations:
PubMed Identifier
32433277
Citation
Soffin EM, Beckman JD, Tseng A, Zhong H, Huang RC, Urban M, Guheen CR, Kim HJ, Cammisa FP, Nejim JA, Schwab FJ, Armendi IF, Memtsoudis SG. Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery. Anesthesiology. 2020 Aug;133(2):350-363. doi: 10.1097/ALN.0000000000003346.
Results Reference
background

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Enhanced Recovery After Spinal Surgery Protocol Versus Conventional Care in Non Insulin Diabetic Patients ( ERAS )

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