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Different Low-flow Sevoflurane Anesthesia Techniques

Sponsor
Kocaeli Derince Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04743193
Collaborator
(none)
60
Enrollment
1
Location
3.3
Actual Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: 2.5 %sevoflurane
  • Other: 8% sevoflurane low flow anesthesia

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Feb 5, 2021
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
May 15, 2021

Arms and Interventions

Arm 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.

Other: 8% sevoflurane low flow anesthesia
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.

Other: 2.5 %sevoflurane
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

Outcome Measures

Primary Outcome Measures

  1. sevoflurane versus desflurane [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.

Secondary Outcome Measures

  1. sevoflurane [studdy will complete in one month]

    Its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tahsin Şimşek İstanbul Kartal Turkey 34000

Sponsors and Collaborators

  • Kocaeli Derince Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tahsin Şimşek, principal investigator, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT04743193
Other Study ID Numbers:
  • 2020-514-169-13
First Posted:
Feb 8, 2021
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tahsin Şimşek, principal investigator, Kocaeli Derince Education and Research Hospital
inhalation
Additional relevant MeSH terms:
Sevoflurane

Study Results

No Results Posted as of Sep 1, 2021