Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation

Not Applicable

• Conditions: Emergence Agitation After Desflurane Anesthesia
• Interventions: Drug: Gabapentin Oral Solution [Neurontin]; Drug: Strawberry juice as (placebo)

• Registration Number: NCT03347916
• Lead Sponsor: Kuwait Specialized Eye Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Status Verified: 2017-11
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-17
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-21
• Primary Completion: 2017-11-25
• Study Completion: 2017-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin group	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.
Control group	Strawberry juice as (placebo)	patients received strawberry juice 5 ml volume, one hour before induction.

Primary Outcome Measures

Name	Time	Method
emergence agitation incidence and scores	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.

Secondary Outcome Measures

Name	Time	Method
duration of emergence	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

Trial Locations

Locations (1)

Kuwait Specialized Eye Center; 🇰🇼 Kuwait, Kuwait