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NCT Number: NCT06613893

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Thoracic Surgery

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

  • 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:
  • Group A will receive total inravenous anesthesia (TIVA).
  • Group B will receive inhalational anesthesia (IHA)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: 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

Primary outcomes

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

    Time frame: Immediate preoperative till 48 hours after recovery from anesthesia

    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)

Secondary outcomes

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

    Time frame: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia

    serum insulin level (pmol/l) 30 min before and 30 min after surgery

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

    Time frame: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia

    serum cortisol level (mcg/dl) 30 min before and 30 min after surgery

  3. The incidence of postoperative complications

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

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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