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

• Sponsor: Inje University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02916407
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Entropion	Drug: Sevoflurane; Drug: Desflurane	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sevoflurane Group The patients will maintained general anesthesia with sevoflurane.	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%.; Other Names: sevofrane
Experimental: Desflurane Group The patients will maintained general anesthesia with desflurane.	Drug: Desflurane; Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.; Other Names: suprane

Outcome Measures

Primary Outcome Measures

1. Extubation Time [30 minutes]

   compare the extubation time between sevoflurane and desflurane group

Secondary Outcome Measures

1. Degree of Postoperative Agitation [30 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haeundae paik hospital, inje university	Busan		Korea, Republic of	612-896

Sponsors and Collaborators

• Inje University

Investigators

• Principal Investigator: Ki Hwa Lee, M.D,, Inje University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 25, 2019

More Information

Publications

None provided.

• Responsible Party: Ki Hwa Lee, Assistant professor, Inje University
• ClinicalTrials.gov Identifier: NCT02916407
• Other Study ID Numbers: 2016-01
• First Posted: Sep 27, 2016
• Last Update Posted: May 3, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Ki Hwa Lee, Assistant professor, Inje University: Anesthesia; Agitation; Extubation
• Additional relevant MeSH terms: Entropion; Sevoflurane; Desflurane

Study Results

Participant Flow

Pre-assignment Detail	A total of 56 patients were enrolled in this study and no patient was dropped.

Arm/Group Title	Sevoflurane Group	Desflurane Group
Arm/Group Description	The patients will maintained general anesthesia with sevoflurane. Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.	The patients will maintained general anesthesia with desflurane. Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.
Period Title: Overall Study
STARTED	28	28
COMPLETED	28	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sevoflurane Group	Desflurane Group	Total
Arm/Group Description	The patients will maintained general anesthesia with sevoflurane. Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.	The patients will maintained general anesthesia with desflurane. Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.	Total of all reporting groups
Overall Participants	28	28	56
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.3 (1.1)	4.6 (1.1)	4.5 (1.1)
Sex: Female, Male (Count of Participants)
Female	13 46.4%	14 50%	27 48.2%
Male	15 53.6%	14 50%	29 51.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	28 100%	28 100%	56 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
South Korea	28 100%	28 100%	56 100%
Height (centimeter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter]	107.8 (7.4)	108.6 (9.9)	108.2 (8.722)

Outcome Measures

1. Primary Outcome

Title	Extubation Time
Description	compare the extubation time between sevoflurane and desflurane group
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

A total of 56 patients were enrolled in this study and no patient was dropped.

Arm/Group Title	Sevoflurane Group	Desflurane Group
Arm/Group Description	The patients will maintained general anesthesia with sevoflurane. Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.	The patients will maintained general anesthesia with desflurane. Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.
Measure Participants	28	28
Mean (Standard Deviation) [seconds]	756.3 (267.2)	425.9 (122.9)

2. Secondary Outcome

Title	Degree of Postoperative Agitation
Description	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.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

A total of 56 patients were enrolled in this study and no patient was dropped.

Arm/Group Title	Sevoflurane Group	Desflurane Group
Arm/Group Description	The patients will maintained general anesthesia with sevoflurane. Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.	The patients will maintained general anesthesia with desflurane. Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.
Measure Participants	28	28
Median (Inter-Quartile Range) [units on a scale]	15	10

Adverse Events

Time Frame	30 minutes after surgery
Adverse Event Reporting Description	There was no serious adverse event.
Arm/Group Title	Sevoflurane Group		Desflurane Group
Arm/Group Description	The patients will maintained general anesthesia with sevoflurane. Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.		The patients will maintained general anesthesia with desflurane. Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.
All Cause Mortality
	Sevoflurane Group		Desflurane Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Serious Adverse Events
	Sevoflurane Group		Desflurane Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Sevoflurane Group		Desflurane Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/28 (17.9%)		1/28 (3.6%)
Respiratory, thoracic and mediastinal disorders
copious secretion	2/28 (7.1%)	2	0/28 (0%)	0
laryngospasm	1/28 (3.6%)	1	1/28 (3.6%)	1
desaturation	2/28 (7.1%)	2	0/28 (0%)	0

Limitations/Caveats

There was non-ketamine (control) group. We used ketamine for reducing of separation anxiety of children.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.