NCT03955406

Brief Summary

The aim of the study is to compare the effectiveness of conventional low flow anesthesia (LFA) with initial high fresh gas flow ( 4L/min) for 10 minutes and LFA with fixed fresh gas flow rate (1L/min).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

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

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 22, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

May 16, 2019

Last Update Submit

July 9, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • The time required to reach 0.7 MAC

    perioperative

  • number of adjustments made to the vaporizer settings

    MAC will be held between 0.6-0.8 with adjustments at the vaporizer

    perioperative

Secondary Outcomes (1)

  • anesthetic agent consumption

    perioperative

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 6% with fresh gas flow rate 4 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 1% higher value than the EtAA concentration required to achieve 0.7 MAC. And after 10 minutes fresh gas flow rate will be reduced to 1L/min.

Procedure: Conventional Low flow Anesthesia

Fixed Fresh Gas Flow Rate group

ACTIVE COMPARATOR

After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 18% with fresh gas flow rate 1 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 2% higher value than the EtAA concentration required to achieve 0.7 MAC.

Procedure: Low Flow Anesthesia with fixed fresh gas flow rate

Interventions

During the initial wash-in period 4 L/min Fresh gas flow will be used.

Conventional group

Fresh gas flow rate will be 1 L/min throughout the procedure.

Fixed Fresh Gas Flow Rate group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-3
  • scheduled for surgery under general anesthesia with endotracheal intubation

You may not qualify if:

  • hemodynamic instability
  • emergency cases
  • expected anesthesia duration \< 60 min
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, In the USA Or Canada, Please Select..., 46100, Turkey (Türkiye)

Location

Related Links

Study Design

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

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 20, 2019

Study Start

May 22, 2019

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations