Skip to main content
OpenTrials
Completed

NCT Number: NCT06558695

Stability Comparison of TIVA and Sevoflurane in Prone Spinal Surgery(TIVA:Total Intravenous Anesthesia)

Key Points:

1. Objective:

o To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries. 2. Methodology:

* A randomized controlled trial involving 52 patients scheduled for lumbar spine surgery, randomly assigned to either TIVA or sevoflurane groups. * Respiratory and hemodynamic parameters were measured at various time points. 3. Results:

* No significant differences were found between the TIVA and sevoflurane groups in terms of respiratory mechanics or hemodynamic stability. * Both anesthesia techniques maintained stable intraoperative conditions. 4. Clinical Implications:

* Anesthesiologists can flexibly choose between TIVA and sevoflurane based on patient-specific factors and surgical requirements. * TIVA may be preferred in surgeries with high neurological risk due to its compatibility with neuromonitoring. 5. Future Research:

* Studies with broader patient populations and long-term outcomes are needed to further refine anesthesia management strategies. * Research on the environmental impact and cost-effectiveness of anesthesia techniques is also important.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

About this study

This study aims to evaluate the impact of total intravenous anesthesia (TIVA) versus sevoflurane anesthesia on respiratory mechanics and hemodynamic parameters during spinal surgery performed in the prone position. Anesthesia management for spinal surgeries in the prone position is particularly challenging due to significant physiological changes. Identifying the effects of different anesthesia techniques is essential to enhance patient outcomes and ensure intraoperative stability. This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The study included male and female patients aged 18 to 65 years who were scheduled for lumbar spine surgery under general anesthesia. Patients were categorized based on the American Society of Anesthesiologists (ASA) physical status levels I, II, and III.

Exclusion criteria

  • Diagnosis of asthma or chronic obstructive pulmonary disease (COPD)
  • Major cardiac conditions, such as recent myocardial infarction or a left ventricular ejection fraction (EF) less than 55%
  • Atrioventricular blocks of second and third degrees
  • Allergies to any drugs
  • Severe neurological disorders
  • History of sedative or opioid use

Treatment and study plan

Sevoflurane

Drug

Sevoflurane was managed for maintenance of the general anestesia during spinal surgeries

TIVA

Drug

TIVA was managed for maintenance of the general anesthesia during spinal surgeries

Other names: Total Intra Venous Anesthesia

Primary outcomes

  1. PEEP

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    positive end-expiratory pressure

  2. ETCO2

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    end-tidal carbon dioxide

  3. VT

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    tidal volume

  4. Ppeak

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    peak airway pressure

  5. Pmean

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    mean airway pressure

  6. RR

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    Respiratory Rate

  7. MV

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    Minute volume

  8. Cdyn

    Time frame: in the supine position after intubation and in the prone position at the 30th minute

    Dynamic. compliance

  9. PaO2/FiO2

    Time frame: in the prone position at the 30th minute

    Partial Oxygen pressure/traction of inspired oxygen

  10. Vd/Vt

    Time frame: in the prone position at the 30th minute

    dead space/tidal volume

Secondary outcomes

  1. HR

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    Heart Rate

  2. SBP

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    Systolic Blood Pressure

  3. DBP

    Time frame: 5, 15, and 30 minutes after positioning in the prone position

    Diastolic BloodPressure

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Comparison of TIVA and Sevoflurane: Affirming Hemodynamic, Respiratory, and Neuromonitoring Stability in Prone Position Spinal Surgeries

Acronym: TIVA

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

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.

Published trials that share one or more normalized conditions with this study.