- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347916
Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation
November 17, 2017 updated by: Ahmed A. Badawy, Kuwait Specialized Eye Center
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
to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed A. BAdawy, MD
- Phone Number: +96597700293
- Email: dr.ahmedbadawy545@gmail.com
Study Contact Backup
- Name: Nicolas Abou chaar, MSSc
- Phone Number: +96597714558
- Email: nicolas.abouchaar@gmail.com
Study Locations
-
-
-
Kuwait, Kuwait, 113111
- Recruiting
- Kuwait Specialized Eye Center
-
Contact:
- Nicolas Abou chaar, MSSc
- Phone Number: +96597714558
- Email: nicolas.abouchaar@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
patients received strawberry juice 5 ml volume, one hour before induction.
|
Patients received strawberry juice 5 ml volume, one hour before induction.
Other Names:
|
Active Comparator: Gabapentin group
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
emergence agitation incidence and scores
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of emergence
Time Frame: through study completion, an average of 1 year
|
The time from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2017
Primary Completion (Anticipated)
November 25, 2017
Study Completion (Anticipated)
November 30, 2017
Study Registration Dates
First Submitted
November 14, 2017
First Submitted That Met QC Criteria
November 15, 2017
First Posted (Actual)
November 20, 2017
Study Record Updates
Last Update Posted (Actual)
November 21, 2017
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dyskinesias
- Psychomotor Disorders
- Delirium
- Psychomotor Agitation
- Emergence Delirium
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Anticonvulsants
- Antimanic Agents
- Gabapentin
Other Study ID Numbers
- kuwaiteyecenter01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emergence Agitation After Desflurane Anesthesia
-
Milton S. Hershey Medical CenterAmbu A/SRecruitingLimit Emergence Phenomena After General AnesthesiaUnited States
-
Xiaoliang GanUnknownChild | Anesthesia | AgitationChina
-
Suez Canal UniversityCompletedDelayed Emergence From AnesthesiaEgypt
-
Bozok UniversityRecruitingElectroencephalography | Anesthesia Complication | Anesthesia Recovery PeriodsTurkey
-
Fundación Pública Andaluza para la gestión de la...Not yet recruitingSevoflurane | Desflurane | Anesthesia | Low Flow Anesthesia
-
Sichuan Provincial People's HospitalNot yet recruitingPostoperative Recovery | Desflurane Anesthesia
-
Jiaxiang ChenActive, not recruiting
-
Second Affiliated Hospital of Nanchang UniversityNot yet recruitingAnesthesia | Emergence Agitation | Children's SurgeryChina
-
Ain Shams UniversityCompletedPediatric Anesthesia | Pediatric ALLEgypt
-
Korea University Anam HospitalUnknown
Clinical Trials on Strawberry juice as (placebo)
-
University of GlasgowScottish Universities Environmental Research CentreCompletedHealthyUnited Kingdom
-
Carl Ade, M.S., Ph.D.California Strawberry CommissionRecruitingObesity | Metabolic SyndromeUnited States
-
USDA Human Nutrition Research Center on AgingCalifornia Strawberry CommissionCompletedAging | Age-related Memory DisordersUnited States
-
Agricultural University of AthensCompletedAppetitive Behavior | Potential Abnormality of Glucose ToleranceGreece
-
Florida State UniversityCalifornia Strawberry CommissionCompletedCardiovascular Diseases | Vascular Diseases | HypertensionUnited States
-
Penn State UniversityCalifornia Strawberry CommissionCompletedCardiovascular DiseaseUnited States
-
Universidad Francisco de VitoriaUniversity of Alcala; University of SevilleCompleted
-
Karolinska InstitutetRecruiting
-
Northumbria UniversityCompletedCognitive Impairment | Cerebrovascular CirculationUnited Kingdom
-
Penn State UniversityActive, not recruitingMetabolic SyndromeUnited States