Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia

• Status: Completed
• Trial end date: 2013-10-08
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are inviting your child to participate in this research study because your child is having myringotomy (putting a tiny incision in the eardrum with or without tube insertion) under general anesthesia.

The purpose of this study is to determine whether a single injection of Dexmedetomidine (study medication) decreases the frequency of awaking from anesthesia frightened or agitated in children having myringotomy surgery as compared to those children who receive placebo (sterile saltwater).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martin Mueller; University of Iowa
• Treatments: Anesthetics; Dexmedetomidine

Criteria

Inclusion Criteria:

• ASA I or II (American Society of Anesthesiology classification ASA I means patients without systemic disease, ASA II means patients with one controlled systemic medical disease eg: Diabetes, Hypertension.)

• Between the ages of 1 and 10 years

• Undergoing BMT under general anesthesia.

Exclusion Criteria:

• ASA III or higher (Patients with 2 or more medical systemic disease that is not under control, eg: uncontrolled Diabetes)

• Congenital diseases

• Coagulation disorders

• Known allergic reaction to dexmedetomidine

• Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal, neurological or endocrine functions

• Severe upper airway infection

• Predicted difficult airway

• Preexisting psychiatric disorders