1-1-8 Wash-in for Sevoflurane Low Flow Anesthesia

August 6, 2018 updated by: Thepakorn Sathitkarnmanee, Khon Kaen University

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%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The benefits of low flow anesthesia are economic, less pollution, more heat and humidity preservation but it requires appropriate wash-in phase. The current wash-in protocols for sevoflurane are complicated and time consuming. The investigators propose a new 1-1-8 sevoflurane wash-in protocol which is more simple and predictable.

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% with 1-1-8 wash-in protocol.

All patients will receive iv propofol 2 mg/kg as induction agent and succinyl choline 1.5 mg/kg for intubation. Then the ventilation will be controlled to achieve end-tidal CO2 30-35 mmHg with O2:N2O or O2:air 1:1 L/min with sevoflurane 8%. Time to achieve alveolar concentration of sevoflurane at 1, 1.5, 2, 2.5, 3, and 3.5% will be recorded and analyzed. After that, the concentration of sevoflurane and anesthetic technique will be adjusted to requirement of anesthesiologist.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Faculty of Medicine, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1-1-8 wash-in
Wash-in using O2:N2O or O2:air 1:1 L/min with sevoflurane 8%
Procedure: 1-1-8 wash-in
wash-in phase during start of low flow anesthesia
Drug: Sevoflurane
Drug used for wash-in protocol
Other Names:
  • Inhalation anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time
Time Frame: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes]
Heart rate (beat/min) at alveolar concentration of sevoflurane of 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]
Blood pressure
Time Frame: participants will be followed until alveolar concentration of sevoflurane reaches 3.5%, as expected of 10 minutes]
Blood pressure (systolic and diastolic (mmHg)) at alveolar concentration of sevoflurane of 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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Thepakorn Sathitkarnmanee, MD, Faculty of Medicine, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE601228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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