Safety of Remifentanil Infusion

NCT ID: NCT01303627

Last Updated: 2012-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.

Conditions

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Urinary Tract Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ultiva,remifentanil,opioid,analgesic

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

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

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

control

Control:Remifentanil stopped at the end of the surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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remifentanil

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* history of hypertension
* asthma and chronic obstructive lung disease
* recent respiratory tract infections
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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derya özkan

MD consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jülide Ergil, MD

Role: STUDY_CHAIR

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

Alp Alptekin, MD

Role: STUDY_CHAIR

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

Nihan Aktürk, MD

Role: STUDY_CHAIR

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

Haluk Gümüs, MD

Role: STUDY_CHAIR

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

Locations

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

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 19864308 (View on PubMed)

Other Identifiers

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DiskapiTRH

Identifier Type: -

Identifier Source: org_study_id

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