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

NCT06558695 | Completed

• 1 other identifier: SaglikBilimleriU-KLKSH-Anes-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Key Points:

• 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.
• 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.
• 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.
• 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.

Conditions

Spinal Stenosis, Lumbosacral Region

Keywords

Total intravenous anesthesia; Sevoflurane; Respiratory mechanics,; Hemodynamic parameters; Spinal surgery; Prone position

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• HR

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

• SBP

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

• DBP

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

Study Arms (2)

Sevoflurane Group

ACTIVE COMPARATOR

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

Drug: Sevoflurane

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.

Drug: TIVA

Interventions

Sevoflurane DRUG

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

Sevoflurane Group

TIVA DRUG

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

Also known as: Total Intra Venous Anesthesia

TIVA group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Yücel Yüce, MD,Assoc Prf

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: May 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)