NCT03510013

Brief Summary

The investigators propose a new wash-in technique for sevoflurane low flow anesthesia with fresh gas flow of O2:N2O or O2:air 1:1 L/min with sevoflurane 8%. The objective of this study is to identify time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5%

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

April 17, 2018

Last Update Submit

August 6, 2018

Conditions

Keywords

low flow anesthesiawash-insevoflurane

Outcome Measures

Primary Outcomes (1)

  • Time

    Time (in second) to achieve alveolar concentration of sevoflurane 1, 1.5, 2, 2.5, 3, and 3.5%

    participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes

Secondary Outcomes (2)

  • Heart rate

    participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes]

  • Blood pressure

    participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes]

Study Arms (1)

1-1-8 wash-in

EXPERIMENTAL

Wash-in using O2:N2O or O2:air 1:1 L/min with sevoflurane 8%

Procedure: 1-1-8 wash-inDrug: Sevoflurane

Interventions

1-1-8 wash-inPROCEDURE

wash-in phase during start of low flow anesthesia

1-1-8 wash-in

Drug used for wash-in protocol

Also known as: Inhalation anesthetic
1-1-8 wash-in

Eligibility Criteria

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

You may qualify if:

  • ASA classification I-II
  • age 18-65 years

You may not qualify if:

  • BMI \> 35
  • contraindicated for N2O
  • with pulmonary or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • Tribuddharat S, Sathitkarnmanee T, Vattanasiriporn N, Thananun M, Nonlhaopol D, Somdee W. 1-1-8 one-step sevoflurane wash-in scheme for low-flow anesthesia: simple, rapid, and predictable induction. BMC Anesthesiol. 2020 Jan 24;20(1):23. doi: 10.1186/s12871-020-0940-2.

MeSH Terms

Interventions

SevofluraneAnesthetics, Inhalation

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsAnesthetics, GeneralAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Thepakorn Sathitkarnmanee, MD

    Faculty of Medicine, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive sevoflurane 8% with O2:N2O or O2:air 1:1 L/min under controlled ventilation. Time to achieve alveolar concentration of sevoflurane of 1%, 1.5%, 2%, 2.5%, 3% and 3.5% will be recorded.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 27, 2018

Study Start

April 1, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations