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NCT Number: NCT07496593

Total Intravenous and 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Abasya, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Propofol + fentanyl + Atracurium

Drug

Group A (TIVA) will not receive any inhaled anesthesia

Isoflurane and Atracurium

Drug

Group B will receive inhaled anesthesia

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

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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