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Sevoflurane Induced Emergence Agitation

NCT ID: NCT02022488

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-08-31

Brief Summary

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Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.

Detailed Description

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Conditions

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Emergence Agitation

Keywords

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Child Sevoflurane Emergence delirium General anesthesia Premedication.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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midazolam and alfentanil

Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

Group M

alfentanil

Intervention Type DRUG

Group MA

midazolam and ketamine

Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

Group M

ketamine

Intervention Type DRUG

Group MK

midazolam

Midazolam 0.5mg/kg

Group Type PLACEBO_COMPARATOR

midazolam

Intervention Type DRUG

Group M

Interventions

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midazolam

Group M

Intervention Type DRUG

alfentanil

Group MA

Intervention Type DRUG

ketamine

Group MK

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1- 8 years
* American Society of Anesthesiologist (ASA) I-II,
* Patients undergoing procedures below the umbilicus

Exclusion Criteria

* cardiac diseases
* pulmonary diseases
* hepatic diseases
* renal diseases
* psychological or emotional disorders
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeditepe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sevgi Bilgen

Yeditepe University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeditepe University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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162

Identifier Type: -

Identifier Source: org_study_id