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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Stenosis, Lumbosacral Region

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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Sevoflurane Group

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

TIVA

Intervention Type DRUG

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

Interventions

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Sevoflurane

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

Intervention Type DRUG

TIVA

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

Intervention Type DRUG

Other Intervention Names

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Total Intra Venous Anesthesia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes