The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery

Entropion Clinical Trial

Official title:

The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916407
• Other study ID #: 2016-01
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2019
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.

Description:

This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• American society of anesthesiologist class 1 patients

• 3-6 years children undergoing entropion surgery

Exclusion Criteria:

• Do not agree with participate this study

Related Conditions & MeSH terms

• Entropion

Intervention

Drug:
• Sevoflurane
Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.
• Desflurane
Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.

Locations

Country	Name	City	State
Korea, Republic of	Haeundae paik hospital, inje university	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation Time	compare the extubation time between sevoflurane and desflurane group	30 minutes
Secondary	Degree of Postoperative Agitation	Postoperative agitation will measure using Pediatric Anesthesia Emergence Delirium (PAED) scale. PAED scale is "(1) The child makes eye contact with the caregiver (2) The child's action are purposeful (3) The child is aware of his/her surrounding (4) The child is restless (5) The child is inconsolable." It scores 0-4, and total maximum score is 20.; PAED score > 12 was used to determine occurence of postoperative agitation.	30 minutes