NCT01171833

Brief Summary

Three groups of patients are going to have minor surgery under general anesthesia with inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg, respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be observed differences among the groups for ventilatory effects on speed of induction. Duration of this randomised controlled trial will be about 3 months. Estimated sample size will be 36 patients(12 in each group).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 13, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

July 28, 2010

Last Update Submit

August 9, 2012

Conditions

Keywords

Anesthetic inductionDesfluraneIsofluraneSevofluraneVentilation

Outcome Measures

Primary Outcomes (1)

  • End-tidal concentrations of isoflurane, sevoflurane and desflurane, and BIS values with hypo-, normo-, hyperventilation

    The inspiratory, and end-tidal concentrations of volatile anesthetics, partial pressure of end-tidal carbon dioxide will be recorded from an S/5 Avance anesthetic workstation (Datex-Ohmeda) and an embedded monitor. BIS values are measured with a BIS monitor.

    at 0, 30, 60, 90, 120, 180, 240, 300, 360, 480, 600, 720 sec after volatile gas starts

Study Arms (3)

Group A(Sevoflurane)

EXPERIMENTAL

Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

Drug: Sevoflurane

Group B(Desflurane)

EXPERIMENTAL

Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

Drug: Desflurane

Group C(Isoflurane)

EXPERIMENTAL

Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

Drug: Isoflurane

Interventions

2.0 vol% prefilled in a corrugated circuit.

Also known as: Sevorane
Group A(Sevoflurane)

6.0 vol% prefilled in a corrugated circuit.

Also known as: Suprane
Group B(Desflurane)

1.2 vol% prefilled in a corrugated circuit.

Also known as: Aerane
Group C(Isoflurane)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA PS I, II
  • Age: 20-60 years male and female
  • Elective schedule with minor surgery
  • BMI \< 30

You may not qualify if:

  • Patients with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
  • Upper airway anomaly or deformity
  • ASA PS III or higher
  • Pregnant women
  • BMI \>= 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

SevofluraneDesfluraneIsoflurane

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Junyong In, MD

    Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 29, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 13, 2012

Record last verified: 2012-08