NCT06810453

Brief Summary

This study aimed to compare the effects of sevoflurane and desflurane used in low-flow anesthesia on thiol-disulfide homeostasis of patients undergoing general anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 14, 2025

Last Update Submit

January 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum thiol-disulfide homeostasis parameters measurement/ calculation

    Serum thiol-disulfide homeostasis parameters were evaluated using an automated method (3). Homeostasis parameters include disulfide, native thiol (NT) and total thiol (TT) levels, and disulfide/TT, NT/TT, and disulfide/NT ratios. TT and NT levels were measured in μmol/L on a Beckman Coulter AU480 analyzer using a commercial kits (Rel Assay Diagnostics, Türkiye). The amount of disulfide was calculated using the formula ((TT-NT) /2). Then, ratios were calculated as percentages

    A 5 cc venous blood sample was obtained just before the anesthesia induction and at the end of surgery.

Study Arms (2)

sevoflurane

OTHER

sevoflurane low-flow anesthesia

Other: A 5 cc venous blood sample was obtainedProcedure: low-flow anesthesia

desflurane

OTHER

desflurane low-flow anesthesia

Other: A 5 cc venous blood sample was obtainedProcedure: low-flow anesthesia

Interventions

A 5 cc venous blood sample was obtained just before anesthesia induction and at the end of surgery.

desfluranesevoflurane

Low-flow anesthesia, also known as inhalational anesthesia method, is a type of anesthesia that is performed using a semi-closed, rebreathing system containing at least 50% fresh gas. Generally, low-flow anesthesia is used in anesthesia practices because it reduces costs, prevents environmental pollution, increases the humidity of gases, and reduces heat loss. Another important benefit of low-flow is that it requires closer monitoring of patients, which allows for early detection of complications during general anesthesia, thus improving patient safety. Concerns about low-flow anesthesia being used infrequently in the past have been addressed by the introduction of modern anesthesia workstations with sophisticated monitoring and safety features, which have made low-flow anesthesia widely used in most centers.

desfluranesevoflurane

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were scheduled to undergo elective total thyroidectomy under general anesthesia

You may not qualify if:

  • Patients with diabetes mellitus, alcohol or drug addiction, smoking habits, expected difficult intubation, morbid obesity, chronic obstructive pulmonary disease, cardiovascular disease and those in pregnancy or lactation period were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elzem Sen

Gaziantep, Sehitkamil, 5327842151, Turkey (Türkiye)

Location

Study Officials

  • Elzem Sen, Assoc Prof

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 14, 2025

First Posted

February 5, 2025

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations