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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03510013
Other study ID # HE601228
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date May 31, 2018

Study information

Verified date August 2018
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA classification I-II

- age 18-65 years

Exclusion Criteria:

- BMI > 35

- contraindicated for N2O

- • with pulmonary or cardiac disease

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
1-1-8 wash-in
wash-in phase during start of low flow anesthesia
Drug:
Sevoflurane
Drug used for wash-in protocol

Locations

Country Name City State
Thailand Faculty of Medicine, Khon Kaen University Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Heart rate 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]
Secondary Blood pressure 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]
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