Clinical trial NCT06613893: Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Thoracic Surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose levels in milligrams per decilitre (mg/dl) at different time points
timeFrame: Immediate preoperative till 48 hours after recovery from anesthesia
Secondary outcomes:
measure: Serum insulin level in picomoles per litre (pmol/l)
timeFrame: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
measure: Serum cortisol level in micrograms per decilitre (mcg/dl)
timeFrame: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
measure: The incidence of postoperative complications
timeFrame: The complications will be assessed on the first, third and seveth post-operative day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Nabila M Abdelaziz, professor
role: STUDY_DIRECTOR
References: