Sevoflurane Induced Emergence Agitation

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022488
• Other study ID #: 162
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: December 26, 2013
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: December 2013
• Source: Yeditepe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 8 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Emergence Agitation
• Psychomotor Agitation

Intervention

Drug:
• midazolam
Group M
• alfentanil
Group MA
• ketamine
Group MK

Locations

Country	Name	City	State
Turkey	Yeditepe University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Anesthesia Emergence Delirium (PAED) score	Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score	7 months	No
Secondary	Parental separation score	Parental separation were evaluated with a 4- point scale in the preoperative period	7 months	No
Secondary	Mask acceptance	The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period	7 months	No