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Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation

Primary Purpose

Emergence Agitation After Desflurane Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Strawberry juice as (placebo)
Gabapentin Oral Solution [Neurontin]
Sponsored by
Kuwait Specialized Eye Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergence Agitation After Desflurane Anesthesia

Eligibility Criteria

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

Inclusion Criteria:

  • pediatric patients (2-6 years old), with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing strabismus surgery (for more than one muscle)

Exclusion Criteria:

  • failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.

Sites / Locations

  • Kuwait Specialized Eye CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Gabapentin group

Arm Description

patients received strawberry juice 5 ml volume, one hour before induction.

patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.

Outcomes

Primary Outcome Measures

emergence agitation incidence and scores
agitation measured by emergence agitation scale: [1= Obtunded with no response to stimuli; 2= Asleep, but responsive to movement and stimuli; 3= Awake and appropriately responsive; and 4= Crying and difficult to console; 5= Wild thrashing behaviour that requires restraint]. A score 4 or 5 was considered as agitation and was treated by IV meperidine 0.5 -1 mg/kg increments.

Secondary Outcome Measures

duration of emergence
The time from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command

Full Information

First Posted
November 14, 2017
Last Updated
November 17, 2017
Sponsor
Kuwait Specialized Eye Center
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1. Study Identification

Unique Protocol Identification Number
NCT03347916
Brief Title
Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation
Official Title
The Role of Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation and Delirium in Children After Strabismus Surgery: A Prospective Randomized Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
November 25, 2017 (Anticipated)
Study Completion Date
November 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuwait Specialized Eye Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation After Desflurane Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients received strawberry juice 5 ml volume, one hour before induction.
Arm Title
Gabapentin group
Arm Type
Active Comparator
Arm Description
patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.
Intervention Type
Drug
Intervention Name(s)
Strawberry juice as (placebo)
Other Intervention Name(s)
Strawberry juice
Intervention Description
Patients received strawberry juice 5 ml volume, one hour before induction.
Intervention Type
Drug
Intervention Name(s)
Gabapentin Oral Solution [Neurontin]
Other Intervention Name(s)
Neurontin
Intervention Description
Patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.
Primary Outcome Measure Information:
Title
emergence agitation incidence and scores
Description
agitation measured by emergence agitation scale: [1= Obtunded with no response to stimuli; 2= Asleep, but responsive to movement and stimuli; 3= Awake and appropriately responsive; and 4= Crying and difficult to console; 5= Wild thrashing behaviour that requires restraint]. A score 4 or 5 was considered as agitation and was treated by IV meperidine 0.5 -1 mg/kg increments.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
duration of emergence
Description
The time from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command
Time Frame
through study completion, an average of 1 year

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: pediatric patients (2-6 years old), with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing strabismus surgery (for more than one muscle) Exclusion Criteria: failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A. BAdawy, MD
Phone
+96597700293
Email
dr.ahmedbadawy545@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Abou Chaar, MsSc
Phone
+96597714558
Email
nicolas.abouchaar@gmail.com
Facility Information:
Facility Name
Kuwait Specialized Eye Center
City
Kuwait
ZIP/Postal Code
113111
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Abou chaar, MSSc
Phone
+96597714558
Email
nicolas.abouchaar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29925328
Citation
Badawy AA, Kasem SA, Rashwan D, Al Menesy T, Adel G, Mokhtar AM, Badawy YA. The role of Gabapentin oral solution in decreasing desflurane associated emergence agitation and delirium in children after stabismus surgery, a prospective randomized double-blind study. BMC Anesthesiol. 2018 Jun 20;18(1):73. doi: 10.1186/s12871-018-0533-5.
Results Reference
derived

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Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation

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