NCT01931683

Brief Summary

The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

August 27, 2013

Last Update Submit

October 13, 2014

Conditions

Drug Usage

Keywords

LMA removalremifentanilpropofol

Outcome Measures

Primary Outcomes (1)

  • smooth removal of LMA

    the response of patients to the removal of LMA (classified as either 'success \[smooth emergence\]' or 'failure') during infusion of remifentanil.

    from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).

Study Arms (1)

remifentanil

EXPERIMENTAL

LMA removal was accomplished when remifentanil was maintained a predetermined concentration throughout the emergence periods.

Drug: remifentanilDevice: laryngeal mask airway (LMA)

Interventions

remifentanilDRUG

The concentration of remifentanil was determined by modified Dixon's up-and-down method, starting from 1.0 ng/ml (0.2 ng/ml as a step size)

Also known as: Ultiva
remifentanil
laryngeal mask airway (LMA)DEVICE

LMA was removed when the patients opened their eyes, and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed

remifentanil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • G-E reflux
  • obesity (BMI\>30)
  • anticipated difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwon, 443-721, South Korea

Location

MeSH Terms

Interventions

RemifentanilLaryngeal Masks

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIntubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jong Yeop Kim, MD

    Ajou University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 29, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

KR(1)