The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University

About this trial

Emergence agitation is a postanesthetic phenomenon that develops in the early phase of recovery from general anesthesia, and is characterized by agitation, disorientation, confusion, and possible violent behavior. Emergence agitation can cause serious events such as self-extubation, bleeding, catheter removal and even falling out of the bed leading to severe injuries . Furthermore, it may lead to injuries to health care providers and increase the demand on human resources.

While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children.

Emergence agitation is a common phenomenon occurring in 22.2% in adult patients undergoing general anesthesia for nasal surgery .

Gabapentin, agamma-aminobutyricacidanalog, binds the voltage-gated calcium channels of the dorsal root ganglion, at α2-δ subunite. Gabapentin binding to these channels reduces the release of excitatory neurotransmitters preventing the propagation of painful stimuli which makes its use helpful in treatment of postoperative pain and agitation with less side effects compared with benzodiazepines and opioids . Gabapentin has been used in controlling acute perioperative conditions like preoperative anxiety, intraoperative attenuation of hemodynamic response to noxious stimuli and post operative pain, delirium and nausea and vomiting.

A previous study examined the effect of oral gabapentin 600 mg in reducing emergence agitation in adult patients undergowing rhinoplasty, but this study will examine the effect of two different doses of oral gabapentin 400 mg and 600 mg in reducing emergence agitation after nasal surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing elective nasal surgery will be eligible for the study.

Disqualifiers

hypersensitivity to gabapentin

patient refusal

epilepsy

neurological or psychological conditions that impair communication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gabapentin 600 mg capsules

    Drug

    21 patients will receive 600 mg oral gabapentin one hour before induction.

  • Gabapentin 400 mg capsules

    Drug

    21 patients will receive 400 mg oral gabapentin one hour before induction.

  • Placebo

    Drug

    21 patients will receive placepo one hour before induction.

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: Gabapentin 600 mg groupActive comparator 1 intervention
Group B: Gabapentin 400 mg groupActive comparator 1 intervention
Group C: control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Asessment of emergence agitation

Asessment of emergence agitation by Richmond Agitation Sedation Scale(RASS) (score +1 or more) maximum value is +4 (combative) andminimum value is - (unarousable)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Duration of emergence

The time in minutes 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
2

Duration of Post Anesthesia Care Unit (PACU)stay

the time in minutes from arrival to Post Anesthesia Care Unit (PACU) to discharge to ward

Time frame
through study completion, an average of 1 year
3

Number of patients had Postoperative pain

Postoperative pain through Numerical Rating Scale (0 represents no pain and 10 represents worst possible pain)

Time frame
through study completion, an average of 1 year
4

Number of patients required postoperative opioids and total dose.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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