- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04743193
Different Low-flow Sevoflurane Anesthesia Techniques
Comparison of the Consumption of Sevoflurane in Two Different Concentrations and Two Different Currents During the Initial Period of Anesthesia in Patients Undergoing General Anesthesia With Minimal Flow
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this study is to compare the instantaneous and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia. Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.
A total of 70 patients between the ages of 18-65 will be included in the study.in 2.5 % sevoflurane grup After reaching 1 MAC level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. in sevoflurane 8 % group for 35 patients, after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC. . The depth of anesthesia for both groups will be measured by the Bispectral Index (BIS). BIS values between 40 and 60 are appropriate values for general anesthesia, for this value 1 MAC sevoflurane inhalation anesthesia and remifentanil infusion (0.1-0.3mcg / kg / min) will be used.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kartal
-
İstanbul, Kartal, Turkey, 34000
- Tahsin Şimşek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Patients between the ages of 18-65
- ASA1,2,3 group patients
Description
Inclusion Criteria:
- Patients between the ages of 18-65
- ASA1,2,3 group patients
- Patients under general anesthesia
- Patients scheduled for elective surgery
Exclusion Criteria:
- The patient's refusal to participate in the study
- Patients with less than 90 minutes of total anesthesia time
- Patients whose total anesthesia time exceeds 180 minutes
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
sevoflurane 8 %
In the initial phase, after reaching 1 (MAK) level with 1lt / min fresh gas flow and 8% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC.
|
For 35 patients after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC. .
|
sevoflurane 2.5 %
In the initial phase, after reaching 1 MAK level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 MAC.
|
for 35 patients after reaching 1 MAK level with 4 lt / min fresh gas flow and 2,5% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 minimum alveolar concentration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sevoflurane versus desflurane
Time Frame: the study will comlete in one month
|
To compare the instant and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia.
|
the study will comlete in one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sevoflurane
Time Frame: studdy will complete in one month
|
Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.
|
studdy will complete in one month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-514-169-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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