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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis, Lumbosacral Region
• Intervention / Treatment: Drug: Sevoflurane; Drug: TIVA

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Saglik Bilimleri Universitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sevoflurane Group; In the Sevoflurane group, general anesthesia was maintained with sevoflurane at 0.8-1.0 minimum alveolar concentration (MAC).	Drug: Sevoflurane; Sevoflurane was managed for maintenance of the general anestesia during spinal surgeries
Active Comparator: TIVA group; In the TIVA (Total Intra Venous Anesthesia) group, a combination of propofol (50-150 μg/kg/min) and remifentanil (0.02-0.2 μg/kg/min) was used for general anesthesia instead of inhalational agents.	Drug: TIVA; TIVA was managed for maintenance of the general anesthesia during spinal surgeries; Other Names: Total Intra Venous Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEEP	positive end-expiratory pressure	5, 15, and 30 minutes after positioning in the prone position
ETCO2	end-tidal carbon dioxide	5, 15, and 30 minutes after positioning in the prone position
VT	tidal volume	5, 15, and 30 minutes after positioning in the prone position
Ppeak	peak airway pressure	5, 15, and 30 minutes after positioning in the prone position
Pmean	mean airway pressure	5, 15, and 30 minutes after positioning in the prone position
RR	Respiratory Rate	5, 15, and 30 minutes after positioning in the prone position
MV	Minute volume	5, 15, and 30 minutes after positioning in the prone position
Cdyn	Dynamic. compliance	in the supine position after intubation and in the prone position at the 30th minute
PaO2/FiO2	Partial Oxygen pressure/traction of inspired oxygen	in the prone position at the 30th minute
Vd/Vt	dead space/tidal volume	in the prone position at the 30th minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR	Heart Rate	5, 15, and 30 minutes after positioning in the prone position
SBP	Systolic Blood Pressure	5, 15, and 30 minutes after positioning in the prone position
DBP	Diastolic BloodPressure	5, 15, and 30 minutes after positioning in the prone position

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Yücel Yüce, MD,Assoc Prf, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Sevoflurane; Prone position; Total intravenous anesthesia; Spinal surgery; Hemodynamic parameters; Respiratory mechanics,
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: SaglikBilimleriU-KLKSH-Anes-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No