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

NCT07496593 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: FMASU MD305/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabete Mellitus; VATS; TIVA

Keywords

Diabetes; VATS; TIVA

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be blood glucose level after one and half hour

  measurement of blood gulcose level

  one and half hour

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.

  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.

Study Arms (2)

Propofol, Fentanyl and Atracurium

ACTIVE COMPARATOR

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

Isoflurane and atracurium

ACTIVE COMPARATOR

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

Interventions

Propofol + fentanyl + Atracurium DRUG

Group A (TIVA) will not receive any inhaled anesthesia

Propofol, Fentanyl and Atracurium

Isoflurane and Atracurium DRUG

Group B will receive inhaled anesthesia

Isoflurane and atracurium

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abasya, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Propofol; Fentanyl; Atracurium; Isoflurane

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Methyl Ethers; Ethers

Study Officials

• Nahed Effat, professor

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: March 27, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)