NCT02973724

Brief Summary

The investigator designed this study to investigate remifentanil effect-site concentration in 95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

November 21, 2016

Last Update Submit

June 8, 2017

Conditions

Drug Usage

Keywords

ExtubationRemifentanilLaryngomicrosurgery

Outcome Measures

Primary Outcomes (1)

  • Number of cough

    Number of cough or a strong and sudden contraction of the abdomen during periextubation periods

    from end of surgery to 5 min after tracheal extubation

Study Arms (1)

Remifentanil

EXPERIMENTAL

Extubation was performed when remifentanil was maintained a predetermined concentration throughout the emergence periods.

Drug: RemifentanilDrug: Propofol anesthesia

Interventions

RemifentanilDRUG

The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)

Also known as: Ultiva
Remifentanil
Propofol anesthesiaDRUG

Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.

Also known as: Fresofol
Remifentanil

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II patients undergoing general anesthesia for laryngomicrosurgery

You may not qualify if:

  • Anticipated difficult airway
  • COPD, Asthma
  • Recent URI (\< 2 weeks)
  • Severe cardiac, hepatic renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 443-721, South Korea

Location

MeSH Terms

Interventions

RemifentanilPropofol

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 25, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)