Total Intravenous and Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy

March 22, 2026 updated by: Aisha Galal El Din Soliman Said Ahmed Donia, Ain Shams University

Comparative Study Between Total Intravenous Anesthesia (TIVA) Versus Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy.

Video-assisted thoracoscopy is a minimally invasive surgical technique used to diagnose and treat problems in chest. Diabetics are more prone to infections, slower wound healing and other complications during and after surgery. Studies suggests that Total Intravenous Anesthesia (TIVA) can lead to a lower increase in blood glucose levels and a better suppression of the stress response compared to balanced anesthesia using inhalational agents like Isoflurane.

In the present study we are aiming to compare the effects of Total Intravenous Anesthesia (TIVA) Versus Balanced Anesthesia on blood glucose level in Diabetic Patients undergoing Video-assisted thoracoscopy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to assess the impact of total intravenous anesthesia and balanced anesthesia as anesthesia maintenance approach on blood glucose level and postoperative complications in diabetic patients undergoing video-assisted thoracoscopy All patients will be kept fasting for 2 hours for clear fluids and 6 hours for meals preoperatively . Oral antidiabetic medications were continued in diabetic patients on the day before surgery, and were discontinued on the day of surgery. The doses of long-acting insulin administered should be reduced by 50-75% on the night before surgery to avoid hypoglycemia during a prolonged fast. Half doses of basal insulin were administered the morning of surgery. Blood glucose level is measured, if hyperglycemia occurred, control of hyperglycemia is done by giving regular insulin. A detailed history, thorough general and physical examination and routine investigations will be done. Patients fulfilling inclusion criteria will be randomly divided into two groups using computer generated random numbers with (30) patients in each group. Group A will receive Total intravenous anesthesia (TIVA). Group B will receive Balanced anesthesia.

Upon arrival to the operating room, standard monitoring including pulse oximetry (spo2), continuous electrocardiogram (ECG) and noninvasive blood pressure (BP) measurement and capnography will be started. Blood glucose level will be measured then a proper sized intravenous access will be inserted under complete aseptic conditions and secured. Blood sample for cortisol will be taken. Midazolam 0.02-0.07 mg/ kg will be given for sedation before induction of anesthesia. An intravenous drip of Ringer lactate will be initiated at a rate of 1-2 ml/kg/h as maintenance fluid and replacement fluid will also be given for fasting which is half of the deficit in the first hour of surgery then quarter of the deficit for the rest of surgery. Fluid deficit is the maintenance rate multiplied by the hours of fasting. Glucocorticoid drugs and nonsteroidal analgesics will not be allowed during the surgery. After proper pre-oxygenation general anesthesia will be induced intravenously by propofol 1.5-2.5 mg /kg, fentanyl1-2 mic / kg and atracurium 0.4-0.5 mg / kg in both groups. Endotracheal tube will be placed and secured. Blood glucose level will be measured.

For patients receiving TIVA (Group A) anesthesia will be maintained with propofol infusion (4-12 mg/kg/h), Fentanyl infusion (1-2 mic /kg/h) and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.

For patients receiving balanced anesthesia (Group B) anesthesia will be maintained with isoflurane 1.5% and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.

The maintenance of anesthesia in both groups will be performed using volume controlled ventilation with oxygen (100%), tidal volume 5-7 ml /kg for ideal body weight, rate is adjusted to maintain normocapnia.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abasya
      • Cairo, Abasya, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient for both sex scheduled for VATS.
  • Age group 18-70 years.
  • Diagnosed diabetes mellitus (Type 1 or 2) HbA1c 6-8 % within 3 months.
  • ASA II and III.

Exclusion Criteria:

  • HbA1c > 8 % or < 6 or preoperative insulin infusion or DKA within 3 months
  • Emergency surgery.
  • Drug allergy.
  • Chronic high-dose steroids.
  • Severe hepatic/ renal impairment, significant arrhythmia or severe LV dysfunction.
  • Patient refusal.
  • Psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol, Fentanyl and Atracurium
For patients receiving TIVA (Group A) anesthesia will be maintained with Propofol infusion (4-12 mg/kg/h), Fentanyl infusion (1-2 mic /kg/h) and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.
Drug: Propofol + fentanyl + Atracurium
Group A (TIVA) will not receive any inhaled anesthesia
Active Comparator: Isoflurane and atracurium
patients receiving balanced anesthesia (Group B) anesthesia will be maintained with isoflurane 1.5% and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.
Drug: Isoflurane and Atracurium
Group B will receive inhaled anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome of this study will be blood glucose level after one and half hour
Time Frame: one and half hour
measurement of blood gulcose level
one and half hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose level and blood cortisol levels . Also the occurrence of postoperative nausea and vomiting, emergence agitation, postoperative laryngospasm and stridor and postoperative pain.
Time Frame: blood glucose level 5 mins after (intubation, extubation, admission to PACU ) and after 2 hours and then every 4 hours for 24 hours. blood cortisol level 5 mins before induction of anesthesia, after one and half hour and then every 4 hours for 24 hours.
measurement of blood glucose level and blood cortisol level
blood glucose level 5 mins after (intubation, extubation, admission to PACU ) and after 2 hours and then every 4 hours for 24 hours. blood cortisol level 5 mins before induction of anesthesia, after one and half hour and then every 4 hours for 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Nahed Effat, professor, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD305/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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