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Completed

NCT Number: NCT02022488

Sevoflurane Induced Emergence Agitation

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.

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Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yeditepe University Hospital

Istanbul, 34752, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Group M

alfentanil

Drug

Group MA

ketamine

Drug

Group MK

Primary outcomes

  1. Pediatric Anesthesia Emergence Delirium (PAED) score

    Time frame: 7 months

    Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score

Secondary outcomes

  1. Parental separation score

    Time frame: 7 months

    Parental separation were evaluated with a 4- point scale in the preoperative period

  2. Mask acceptance

    Time frame: 7 months

    The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period

Sponsors and collaborators

Lead sponsor

Yeditepe University Hospital

Other

Registry information

Official study title

Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 27, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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