Sevoflurane Induced Emergence Agitation

Phase 4

Completed

• Conditions: Emergence Agitation
• Interventions: Drug: midazolam; Drug: alfentanil; Drug: ketamine

• Registration Number: NCT02022488
• Lead Sponsor: Yeditepe University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-26
• Study First Posted: 2013-12-27
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam and alfentanil	midazolam	Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
midazolam	midazolam	Midazolam 0.5mg/kg
midazolam and ketamine	midazolam	Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
midazolam and alfentanil	alfentanil	Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
midazolam and ketamine	ketamine	Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)

Primary Outcome Measures

Name	Time	Method
Pediatric Anesthesia Emergence Delirium (PAED) score	7 months	Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score

Secondary Outcome Measures

Name	Time	Method
Parental separation score	7 months	Parental separation were evaluated with a 4- point scale in the preoperative period
Mask acceptance	7 months	The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period

Trial Locations

Locations (1)

Yeditepe University Hospital; 🇹🇷 Istanbul, Turkey