NCT01082458

Brief Summary

Target concentration infusion(TCI) of remifentanil (2.0ng/ml) suppresses the cough induced by endotracheal tube more effectively than intravenous administration of lidocaine (1.5mg/kg).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

March 4, 2010

Last Update Submit

November 18, 2010

Conditions

Thyroidectomy

Keywords

Patients scheduled to undergo thyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Comparison of lidocaine and remifentanil for the effect on responses to the endotracheal tube during emergence from general anesthesia

    The incidence and the grade of cough during emergence from general anensthesia between remifentanil TCI group and lidocaine IV administration group.

Interventions

remifentanil / lidocaineDRUG

Remifentanil TCI group : target controlled infusion of 2.0ng/ml of remifentanil on end of surgery. Lidocaine IV group : Intravenous administration of 1.5mg/kg of lidocaine on end of surgery.

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females older than 20 years old

You may not qualify if:

  • Patients with acute or chronic respiratory disease, hypertension, gastro-esophageal reflux disease, having preoperative sedatives or mucolytics, and current smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

RemifentanilLidocaine

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 8, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

KR(1)