Dexmedetomidine for Laryngeal Mask Airway Insertion

NCT ID: NCT01852539

Last Updated: 2014-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-08-31

Brief Summary

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The investigators attempted to determine the optimal dose of dexmedetomidine required for the successful insertion of LMA during propofol induction without a neuromuscular blocking agent.

Detailed Description

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After a predetermined bolus dose of dexmedetomidine was injected over 2 min, anesthesia was induced with propofol 2.0 mg/kg. After confirming the loss of eyelash reflex and the bispectral index (BIS) score decreased below 60, the insertion of LMA was attempted.

Conditions

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Drug Usage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexmedetomidine

After intravenous infusion of dexmedetomidine for 2 min, propofol 2.0 mg/kg was administrated. And laryngeal mask airway device was inserted(LMA # 3,4).

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

The dose of dexmedetomidine was determined by modified Dixon's up-and-down method, starting from 0.5 μg/kg (0.1 μg/kg as a step size).

propofol

Intervention Type DRUG

Propofol 2.0 mg/kg was administrated

laryngeal mask airway (LMA)

Intervention Type DEVICE

The insertion of laryngeal mask airway (LMA) was attempted, after confirming the loss of eyelash reflex,the bispectral index (BIS) score decreased below 60.

Interventions

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dexmedetomidine

The dose of dexmedetomidine was determined by modified Dixon's up-and-down method, starting from 0.5 μg/kg (0.1 μg/kg as a step size).

Intervention Type DRUG

propofol

Propofol 2.0 mg/kg was administrated

Intervention Type DRUG

laryngeal mask airway (LMA)

The insertion of laryngeal mask airway (LMA) was attempted, after confirming the loss of eyelash reflex,the bispectral index (BIS) score decreased below 60.

Intervention Type DEVICE

Other Intervention Names

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precedex 2% fresofol

Eligibility Criteria

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Inclusion Criteria

* ASA I-II patients undergoing general anesthesia for short elective surgery (\<1 hr)

Exclusion Criteria

* G-E reflux
* obesity (BMI\>30)
* anticipated difficult airway
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jong Yeop Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Yeop Kim, MD

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

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Ajou University School of Medicine

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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Uzumcugil F, Canbay O, Celebi N, Karagoz AH, Ozgen S. Comparison of dexmedetomidine-propofol vs. fentanyl-propofol for laryngeal mask insertion. Eur J Anaesthesiol. 2008 Aug;25(8):675-80. doi: 10.1017/S0265021508004213. Epub 2008 Apr 10.

Reference Type RESULT
PMID: 18400141 (View on PubMed)

Other Identifiers

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AJIRB-MED-CT4-13-045

Identifier Type: -

Identifier Source: org_study_id

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