NCT01303627

Brief Summary

The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 18, 2012

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

28 days

First QC Date

February 24, 2011

Results QC Date

January 30, 2012

Last Update Submit

June 15, 2012

Conditions

Urinary Tract Problem

Keywords

RemifentanilLaryngeal mask airway removalHemodynamic changingInfusionUreterorenoscopy

Outcome Measures

Primary Outcomes (1)

  • Smooth cLMA Removal Condition (Score 1)

    cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)

    At the end of the surgery

Study Arms (2)

ultiva,remifentanil,opioid,analgesic

ACTIVE COMPARATOR

Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery

Drug: remifentanil

control

NO INTERVENTION

Control:Remifentanil stopped at the end of the surgery

Interventions

remifentanilDRUG

1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.

ultiva,remifentanil,opioid,analgesic

Eligibility Criteria

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

You may qualify if:

  • ASA I-II status
  • aged 18-60 years old
  • presenting for ureterorenoscopy

You may not qualify if:

  • history of hypertension
  • asthma and chronic obstructive lung disease
  • recent respiratory tract infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (1)

  • Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.

    PMID: 19864308RESULT

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

The limitation of our study is age and ASA status of the included patients'. The relatively older or ASA status III,IV population may interfere the effect-site concentration TCI of remifentanil

Results Point of Contact

Title
Derya Özkan MD
Organization
Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital 1. Anesthesiology
derya_z@yahoo.com
0903125962553

Study Officials

  • Jülide Ergil, MD

    Ministry of Health Dıskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1.

    STUDY CHAIR

  • Alp Alptekin, MD

    Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1

    STUDY CHAIR

  • Nihan Aktürk, MD

    Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital , Anesthesiology 1

    STUDY CHAIR

  • Haluk Gümüs, MD

    Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD consultant

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

June 25, 2012

Results First Posted

June 18, 2012

Record last verified: 2012-06

Locations

TU(1)