Clinical trial NCT06558695: Stability Comparison of TIVA and Sevoflurane in Prone Spinal Surgery(TIVA:Total Intravenous Anesthesia)
Official title: Comparison of TIVA and Sevoflurane: Affirming Hemodynamic, Respiratory, and Neuromonitoring Stability in Prone Position Spinal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis, Lumbosacral Region
Keywords: Total intravenous anesthesia
Sevoflurane
Respiratory mechanics,
Hemodynamic parameters
Spinal surgery
Prone position
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PEEP
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: ETCO2
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: VT
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: Ppeak
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: Pmean
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: RR
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: MV
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: Cdyn
timeFrame: in the supine position after intubation and in the prone position at the 30th minute
measure: PaO2/FiO2
timeFrame: in the prone position at the 30th minute
measure: Vd/Vt
timeFrame: in the prone position at the 30th minute
Secondary outcomes:
measure: HR
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: SBP
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
measure: DBP
timeFrame: 5, 15, and 30 minutes after positioning in the prone position
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Yücel Yüce, MD,Assoc Prf
role: PRINCIPAL_INVESTIGATOR
References: