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

Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose Level in Type 2 Diabetes Mellitus Patients Undergoing Thoracic Surgery : a Comparative Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracic Surgery; Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Drug: Inhalational anesthesia; Drug: TIVA

Detailed Description

• Type of Study: prospective , randomized .
• Study Settings: Ain Shams University hospitals, Cairo, Egypt.
• Study period: 12 months starting from janurary 2024 .

• Study Population: All adult type 2 diabetic patients (30-70 year old) with class II,III based on the American Society of Anesthesiologists (ASA) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:

  1. Group A will receive total inravenous anesthesia (TIVA).
  2. Group B will receive inhalational anesthesia (IHA)

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A will receive total inravenous anesthesia (TIVA); 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	Drug: TIVA; Anesthesia will be maintained by total intravenous anesthesia with propofol infusion (4 to 12 mcg/kg/min) and fentanyl infusion (3-4.8 mcg /kg/hour)(Ting 2019) 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; Other Names: Fentanyl; propofol
Active Comparator: Group B will receive inhalational anesthesia (IHA); patients in this group will receive inhalational anesthesia using isoflurane, tested variables will be measured according to the protocol	Drug: Inhalational anesthesia; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum insulin level in picomoles per litre (pmol/l)	serum insulin level (pmol/l) 30 min before and 30 min after surgery	30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
Serum cortisol level in micrograms per decilitre (mcg/dl)	serum cortisol level (mcg/dl) 30 min before and 30 min after surgery	30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
The incidence of postoperative complications	The complications that will be tested Acute coronary syndrome. Stroke. acute kidney injury. stress gastric ulcer. surgical site infection. Hypoglycaemia (blood glucose level below 70 mg/dL). Hyperglycemia (fasting blood glucose level greater than 125mg/dL while 2 hours postprandial greater than 200 mg/dL). Postoperative nausea and vomiting . postoperative pulmonary complications including atelectasis, pneumonia and respiratory failure	The complications will be assessed on the first, third and seveth post-operative day

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nabila M Abdelaziz, professor, Ain shams university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol; Fentanyl
• Other Study ID Numbers: FMASU@MD331/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No