Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients

NCT06613893 | Active Not Recruiting

• 1 other identifier: FMASU@MD331/2023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . All participants had to understand and give written informed consent , and ethical committee approval (of Faculty of Medicine, Ain Shams University) will be obtained before participants allocation.

Conditions

Type 2 Diabetes Mellitus (T2DM); Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Blood glucose levels in milligrams per decilitre (mg/dl) at different time points

  Blood glucose levels in milligrams per deciliter at different time points: preoperative (T0), post-intubation (T1), 1st , 2nd and 3rd hour after the start of the operation (T3, T4 and T5, respectively), 1st hour after the operation (T6) , 2nd hour after the operation (T7), 1st and 2nd day after the operation (T8, T9)

  Immediate preoperative till 48 hours after recovery from anesthesia

Secondary Outcomes (3)

• Serum insulin level in picomoles per litre (pmol/l)

  30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia

• Serum cortisol level in micrograms per decilitre (mcg/dl)

  30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia

• The incidence of postoperative complications

  The complications will be assessed on the first, third and seveth post-operative day

Study Arms (2)

Group A will receive total inravenous anesthesia (TIVA)

ACTIVE COMPARATOR

patients in this group will receive total intravenous anesthesia using propofol infusion after induction of anesthesia, tested variables will be measured according to the protocol

Group B will receive inhalational anesthesia (IHA)

ACTIVE COMPARATOR

patients in this group will receive inhalational anesthesia using isoflurane, tested variables will be measured according to the protocol

Drug: Inhalational anesthesia

Interventions

TIVA DRUG

Anesthesia will be maintained by total intravenous anesthesia with propofol infusion (4 to 12 mcg/kg/min) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline

Also known as: Fentanyl, propofol

Inhalational anesthesia DRUG

Anesthesia will be maintained with inhaled isoflurane, Iso-MAC from (0.7 to 1.4%)(Hawkley, Preston, and Maani 2018) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline

Group B will receive inhalational anesthesia (IHA)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 - 70 years
• Sex: Both sexes
• Patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs
• Patients with ASA classification II,III
• Duration of surgery (≥2 h)

You may not qualify if:

• Declining to give written informed consent
• ASA classification Ⅳ to V
• Severe systemic diseases
• Metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood Glucose more than 140 mg/dl)
• Hepatic and/or renal dysfunction
• Neuromuscular disease
• Pancreatic cancer
• History of malignant hyperthermia
• Emergency surgery
• Ischemic heart disease and valvular heart disease
• Body mass index more than 40
• Diabetic patients on insulin therapy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fentanyl; Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nabila M Abdelaziz, professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 26, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)