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Clinical Trials/NCT06613893
NCT06613893
Active, not recruiting
Not Applicable

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

Ain Shams University1 site in 1 country84 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Inhalational anesthesia
Conditions
Type 2 Diabetes Mellitus (T2DM)
Sponsor
Ain Shams University
Enrollment
84
Locations
1
Primary Endpoint
Blood glucose levels in milligrams per decilitre (mg/dl) at different time points
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
June 30, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yasser Alaa Abdalmonim

Principal Investigator

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Age 30 - 70 years Sex: Both sexes Pateints with type 2 diabetes mellitus controlled with oral hypoglycemics Patients with ASA classificaion 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

Arms & Interventions

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

Intervention: Inhalational anesthesia

Outcomes

Primary Outcomes

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

  • The incidence of postoperative complications(The complications will be assessed on the first, third and seveth post-operative day)
  • 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)

Study Sites (1)

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