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Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

Primary Purpose

Inhalational Anesthetics Adverse Reaction, Delirium on Emergence, Strabismus Following Ocular Surgery

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Saline
Sponsored by
Yao Yusheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inhalational Anesthetics Adverse Reaction

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia

Exclusion Criteria:

  • mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

Sites / Locations

  • Fujian Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine group

Midazolam group

Placebo Group

Arm Description

The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia

The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.

The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia

Outcomes

Primary Outcome Measures

Emergence agitation
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores>= 10 were regarded as presence of agitation.

Secondary Outcome Measures

Postoperative vomiting
Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more

Full Information

First Posted
June 28, 2013
Last Updated
January 2, 2015
Sponsor
Yao Yusheng
Collaborators
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01895023
Brief Title
Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children
Official Title
Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yao Yusheng
Collaborators
West China Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families. Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.
Detailed Description
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores < 10 were interpreted as an absence of agitation, scores>= 10 were regarded as presence of agitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalational Anesthetics Adverse Reaction, Delirium on Emergence, Strabismus Following Ocular Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia
Arm Title
Midazolam group
Arm Type
Active Comparator
Arm Description
The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
alpha2-adrenoceptor agonist
Intervention Description
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
GABA modulators
Intervention Description
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
sodium chloride injection (0.9%Nacl)
Intervention Description
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Primary Outcome Measure Information:
Title
Emergence agitation
Description
Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points. A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores>= 10 were regarded as presence of agitation.
Time Frame
participants will be followed for the duration of PACU stay, an expected average of 1 hour
Secondary Outcome Measure Information:
Title
Postoperative vomiting
Description
Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more
Time Frame
up to 24 hours
Other Pre-specified Outcome Measures:
Title
Children's pain
Description
A Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) was used to measure five categories of pain related behaviour, each scored from 0, 1 or 2, for a maximum score of 10.
Time Frame
participants will be followed for the duration of PACU stay, an expected average of 1 hour
Title
Time of emergence
Description
the time to the first response to a simple verbal command
Time Frame
up to 1 hour
Title
Duration of PACU stay
Description
The subject was discharged from the PACU when they met the institutional guidelines of level of consciousness and comfort.
Time Frame
participants will be followed for the duration of PACU stay, an expected average of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia Exclusion Criteria: mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusheng Yao, M.D.
Organizational Affiliation
Fujian Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32976205
Citation
Yao Y, Sun Y, Lin J, Chen W, Lin Y, Zheng X. Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1143-1149. doi: 10.1097/EJA.0000000000001270.
Results Reference
derived

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Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

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