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

Ain Shams University

Status: Active, not recruiting

Conditions: Type 2 Diabetes Mellitus (T2DM); Thoracic Surgery

Treatments: Drug: TIVA; Drug: Inhalational anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06613893

FMASU@MD331/2023

Details and patient eligibility

About

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.

Full 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)

Enrollment: 84 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Group A will receive total inravenous anesthesia (TIVA)

Active Comparator group

Description:

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 group

Description:

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

Treatment:

Drug: Inhalational anesthesia