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Clinical Trials/NCT06558695
NCT06558695CompletedNot Applicable

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

Saglik Bilimleri Universitesi1 site in 1 country52 target enrollmentStarted: May 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
1
Primary Endpoint
ETCO2

Study Overview

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.
  1. 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.
  1. 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.
  1. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Participants were randomly assigned to one of two groups using a computer-generated list: the Sevoflurane group (Sevo group) and the Total Intravenous Anesthesia group (TIVA group), each comprising 26 patients. The assignment and subsequent anesthesia management were conducted in a double-blinded manner, ensuring that neither the patients nor the clinicians administering the treatments or assessing the outcomes were aware of the group allocations

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Sevoflurane Group

Active Comparator

In the Sevoflurane group, general anesthesia was maintained with sevoflurane at 0.8-1.0 minimum alveolar concentration (MAC).

Intervention: Sevoflurane (Drug)

TIVA group

Active Comparator

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.

Intervention: TIVA (Drug)

Outcomes

Primary Outcomes

ETCO2

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

end-tidal carbon dioxide

Pmean

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

mean airway pressure

Vd/Vt

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

dead space/tidal volume

PaO2/FiO2

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

Partial Oxygen pressure/traction of inspired oxygen

PEEP

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

positive end-expiratory pressure

VT

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

tidal volume

Ppeak

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

peak airway pressure

RR

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

Respiratory Rate

Cdyn

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

Dynamic. compliance

MV

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

Minute volume

Secondary Outcomes

  • SBP(5, 15, and 30 minutes after positioning in the prone position)
  • HR(5, 15, and 30 minutes after positioning in the prone position)
  • DBP(5, 15, and 30 minutes after positioning in the prone position)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

YÜCEL YÜCE

Associate Professor

Saglik Bilimleri Universitesi

Study Sites (1)

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