NCT07271472

Brief Summary

The primary objective of our study is to compare the effects of total intravenous anesthesia (TIVA), combined intravenous-volatile anesthesia (CIVA), and balanced anesthesia (BAL) methods on perioperative oxidative stress parameters, such as Malondialdehyde (MDA), Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Superoxide Dismutase (SOD), in patients undergoing video-assisted thoracoscopic surgery (VATS). The secondary objective is to record perioperative vital parameters, arterial blood gas values obtained at specific stages of the surgery, and the incidence of postoperative nausea and vomiting (PONV).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2026

Completed
Last Updated

January 5, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

November 25, 2025

Last Update Submit

January 1, 2026

Conditions

Keywords

Video-Assisted Thoracoscopic SurgeryTotal Intravenous AnesthesiaCombined Intravenous Volatile AnesthesiaBalanced AnesthesiaMalondialdehydeTotal Oxidant StatusTotal Antioxidant StatusSuperoxide Dismutase

Outcome Measures

Primary Outcomes (4)

  • Malondialdehyde levels in perioperatively collected blood samples

    For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of MDA will be measured using the ELISA method.

    Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation

  • Total Antioxidant Status levels in perioperatively collected blood samples

    For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of TAS will be measured using the ELISA method.

    Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation

  • Total Oxidant Status levels in perioperatively collected blood samples

    For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of TOS will be measured using the ELISA method.

    Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation

  • Superoxide Dismutase levels in perioperatively collected blood samples

    For measurement of this marker, arterial blood samples will be collected from the radial artery at three time points: immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation. The collected blood samples will be centrifuged at +4 °C at 4500 rpm for 7 minutes. The obtained serum samples will be transferred into Eppendorf tubes and stored at -80 °C until the day of analysis. Serum levels of SOD will be measured using the ELISA method.

    Immediately before anesthesia induction, before the transition from one-lung ventilation to two-lung ventilation, and 30 minutes after the re-establishment of two-lung ventilation

Secondary Outcomes (3)

  • Postoperative nausea and vomiting

    From 1 to 24 hour post operatively

  • Partial pressure of oxygen (PaO₂) values

    During anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to two-lung ventilation

  • Partial pressure of carbon dioxide pressure (PaCO₂)

    During anesthesia induction, at 15, 30, 45, and 60 minutes of one-lung ventilation, and 30 minutes after the transition to two-lung ventilation

Study Arms (3)

Total Intravenous Anesthesia (TIVA) Group

EXPERIMENTAL

Anesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60.

Drug: Total Intravenous Anesthesia (TIVA) Group

Balanced Anesthesia (BAL) Group

EXPERIMENTAL

Induction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60.

Drug: Balanced Anesthesia (BAL) Group

Combined Intravenous Volatile Anesthesia (CIVA) Group

EXPERIMENTAL

Induction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60.

Drug: Combined Intravenous Volatile Anesthesia

Interventions

Anesthesia induction will include 2 mg midazolam, 2-2.5 mg/kg propofol, 0.6-0.9 mg/kg rocuronium, and 1 μg/kg remifentanil. Maintenance will be provided with target-controlled infusion (TCI) propofol at a Ce of 4-6 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL while maintaining the bispectral index (BIS) between 40-60.

Also known as: TIVA Group
Total Intravenous Anesthesia (TIVA) Group

Induction will follow the same protocol as the TIVA group. During maintenance, desflurane 5-7% (MAC 1-1.3) and TCI remifentanil at a Ce of 1.5-3 ng/mL will be administered, targeting a BIS value between 40-60.

Also known as: BAL Group
Balanced Anesthesia (BAL) Group

Induction will follow the same protocol as other groups. Maintenance will include TCI propofol at a Ce of 2-4 μg/mL and TCI remifentanil at a Ce of 1.5-3 ng/mL along with 3% desflurane (MAC 0.5), keeping BIS values between 40-60.

Also known as: CIVA Group
Combined Intravenous Volatile Anesthesia (CIVA) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65 years,
  • American Society of Anesthesiologists (ASA) Physical Status Class I-II,
  • Scheduled for elective Video-Assisted Thoracoscopic Surgery (VATS)
  • Requiring one-lung ventilation for more than 60 minutes

You may not qualify if:

  • Refusal to participate in the study
  • History of allergy to the drugs to be used
  • Recent history of vitamin supplementation
  • History of severe cardiac, renal, or hepatic disease
  • ASA III-IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

RECRUITING

Related Publications (11)

  • Comhair SA, Erzurum SC. Antioxidant responses to oxidant-mediated lung diseases. Am J Physiol Lung Cell Mol Physiol. 2002 Aug;283(2):L246-55. doi: 10.1152/ajplung.00491.2001.

  • Lang JD, McArdle PJ, O'Reilly PJ, Matalon S. Oxidant-antioxidant balance in acute lung injury. Chest. 2002 Dec;122(6 Suppl):314S-320S. doi: 10.1378/chest.122.6_suppl.314s.

  • Cheng YJ, Chan KC, Chien CT, Sun WZ, Lin CJ. Oxidative stress during 1-lung ventilation. J Thorac Cardiovasc Surg. 2006 Sep;132(3):513-8. doi: 10.1016/j.jtcvs.2006.03.060.

  • Sharifian Attar A, Tabari M, Rahnamazadeh M, Salehi M. A comparison of effects of propofol and isoflurane on arterial oxygenation pressure, mean arterial pressure and heart rate variations following one-lung ventilation in thoracic surgeries. Iran Red Crescent Med J. 2014 Feb;16(2):e15809. doi: 10.5812/ircmj.15809. Epub 2014 Feb 8.

  • Xu WY, Wang N, Xu HT, Yuan HB, Sun HJ, Dun CL, Zhou SQ, Zou Z, Shi XY. Effects of sevoflurane and propofol on right ventricular function and pulmonary circulation in patients undergone esophagectomy. Int J Clin Exp Pathol. 2013 Dec 15;7(1):272-9. eCollection 2014.

  • Schwarzkopf K, Schreiber T, Preussler NP, Gaser E, Huter L, Bauer R, Schubert H, Karzai W. Lung perfusion, shunt fraction, and oxygenation during one-lung ventilation in pigs: the effects of desflurane, isoflurane, and propofol. J Cardiothorac Vasc Anesth. 2003 Feb;17(1):73-5. doi: 10.1053/jcan.2003.13.

  • Loer SA, Scheeren TW, Tarnow J. Desflurane inhibits hypoxic pulmonary vasoconstriction in isolated rabbit lungs. Anesthesiology. 1995 Sep;83(3):552-6. doi: 10.1097/00000542-199509000-00014.

  • Karzai W, Haberstroh J, Priebe HJ. Effects of desflurane and propofol on arterial oxygenation during one-lung ventilation in the pig. Acta Anaesthesiol Scand. 1998 Jul;42(6):648-52. doi: 10.1111/j.1399-6576.1998.tb05296.x.

  • Eisenkraft JB. Effects of anaesthetics on the pulmonary circulation. Br J Anaesth. 1990 Jul;65(1):63-78. doi: 10.1093/bja/65.1.63. No abstract available.

  • Lumb AB, Slinger P. Hypoxic pulmonary vasoconstriction: physiology and anesthetic implications. Anesthesiology. 2015 Apr;122(4):932-46. doi: 10.1097/ALN.0000000000000569.

  • Dunham-Snary KJ, Wu D, Sykes EA, Thakrar A, Parlow LRG, Mewburn JD, Parlow JL, Archer SL. Hypoxic Pulmonary Vasoconstriction: From Molecular Mechanisms to Medicine. Chest. 2017 Jan;151(1):181-192. doi: 10.1016/j.chest.2016.09.001. Epub 2016 Sep 16.

MeSH Terms

Interventions

Population GroupsBalanced Anesthesia

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsAnesthesia, GeneralAnesthesiaAnesthesia and Analgesia

Study Officials

  • Elif Oral Ahiskalioglu, Professor

    Ataturk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Oral Ahiskalioglu, Professor

CONTACT

Mehmet Z Guney, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 9, 2025

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 2, 2026

Last Updated

January 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional regulations. Data will be securely stored and used solely for the purposes of this study and related scientific publications.

Locations