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

NCT05033899 | Completed DMC

• 1 other identifier: ERAS diabetic spine surgery
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

ERAS; Surgery; Non Insulin Dependent Diabetes Mellitus; Lumbar Spine Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative day 2

Secondary Outcomes (11)

• heart rate

  surgery period

• mean arterial blood pressure

  surgery period

• Postoperative pain score

  8 hours postoperative

• Perioperative nalbuphine requirements

  24 hours postoperative

• postoperative hospital stay

  postoperative day 5

Study Arms (2)

group E: ERAS group

EXPERIMENTAL

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

Other: ERAS protocol

group C: conventional group

NO INTERVENTION

conventional perioperative care.

Interventions

ERAS protocol OTHER

to compare between Enhanced Recovery After Surgery (ERAS) protocol and conventional care in non-insulin dependent diabetic patients undergoing lumbar spine surgery.

Also known as: enhanced recovery after surgery protocol

group E: ERAS group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32433277 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Spinal Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• ashraf arafat, MD

  Alexandria University

  STUDY DIRECTOR

• Emad Abdelmoneim arida, MD

  Alrxandria university

  STUDY DIRECTOR

• Rania Aboelfetouh, MD

  Alexandria University

  STUDY DIRECTOR

• Abdulrahman Elhabashy, MD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, alexandria university

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: May 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months up to 1 year
• Access Criteria: ERAS, lumbar spine surgery, non insulin diabetic patients, quality of recovery

Locations

EG (1)