Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation

Emergence Agitation After Desflurane Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03347916
• Other study ID #: kuwaiteyecenter01
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2017
• Last updated: November 17, 2017
• Start date: January 5, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: November 2017
• Source: Kuwait Specialized Eye Center
• Contact: Ahmed A. BAdawy, MD
• Phone: +96597700293
• Email: dr.ahmedbadawy545[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 30, 2017
• Est. primary completion date: November 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergence Agitation After Desflurane Anesthesia
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Strawberry juice as (placebo)
Patients received strawberry juice 5 ml volume, one hour before induction.
• Gabapentin Oral Solution [Neurontin]
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.

Locations

Country	Name	City	State
Kuwait	Kuwait Specialized Eye Center	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Kuwait Specialized Eye Center

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Secondary	duration of emergence	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