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Active Not RecruitingNCT07496593

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

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

Status
Active Not Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGPropofol + fentanyl + AtracuriumGroup A (TIVA) will not receive any inhaled anesthesia
DRUGIsoflurane and AtracuriumGroup B will receive inhaled anesthesia

Timeline

Start date
2025-12-01
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2026-03-27
Last updated
2026-03-27

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07496593. Inclusion in this directory is not an endorsement.