Sevoflurane Induced Emergence Agitation

Yeditepe University Hospital

Status and phase: Completed; Phase 4

Conditions: Emergence Agitation

Treatments: Drug: midazolam; Drug: ketamine; Drug: alfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02022488

162

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 3 patient groups, including a placebo group

midazolam and alfentanil

Active Comparator group

Description:

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

Treatment:

Drug: alfentanil

Drug: midazolam

midazolam and ketamine

Active Comparator group

Description:

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

Treatment:

Drug: ketamine

Drug: midazolam

midazolam

Placebo Comparator group

Description:

Midazolam 0.5mg/kg

Treatment:

Drug: midazolam