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

NCT02916407 | Completed Results

• 1 other identifier: 2016-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Entropion

Keywords

Anesthesia; Agitation; Extubation

Outcome Measures

Primary Outcomes (1)

• Extubation Time

  compare the extubation time between sevoflurane and desflurane group

  30 minutes

Secondary Outcomes (1)

• Degree of Postoperative Agitation

  30 minutes

Study Arms (2)

Sevoflurane Group

ACTIVE COMPARATOR

The patients will maintained general anesthesia with sevoflurane.

Drug: Sevoflurane

Desflurane Group

EXPERIMENTAL

The patients will maintained general anesthesia with desflurane.

Drug: Desflurane

Interventions

Sevoflurane DRUG

Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%.

Also known as: sevofrane

Sevoflurane Group

Desflurane DRUG

Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%.

Also known as: suprane

Desflurane Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American society of anesthesiologist class 1 patients
• years children undergoing entropion surgery

You may not qualify if:

• Do not agree with participate this study

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Haeundae paik hospital, inje university

Busan, 612-896, South Korea

Location

MeSH Terms

Conditions

Entropion; Psychomotor Agitation

Interventions

Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Limitations and Caveats

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

Results Point of Contact

• Title: Dr Ki Hwa Lee
• Organization: Inje University, Haeundae Paik hospital

tedy3333@naver.com

82-51-797-0421

Study Officials

• Ki Hwa Lee, M.D,

  Inje University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 3, 2019
• Results First Posted: May 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)