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

Phase 3

Not yet recruiting

• Conditions: Emergence Agitation
• Interventions: Drug: Gabapentin 600 mg capsules; Drug: Gabapentin 400 mg capsules; Drug: Placebo

• Registration Number: NCT06887998
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-02
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 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.

Exclusion Criteria

1. hypersensitivity to gabapentin
2. patient refusal
3. epilepsy
4. neurological or psychological conditions that impair communication.
5. current use of gabapentin, psychotropic or opioids medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin 600 mg group	Gabapentin 600 mg capsules	21 patients will receive 600 mg oral gabapentin one hour before induction.
Gabapentin 400 mg group	Gabapentin 400 mg capsules	21 patients will receive 400 mg oral gabapentin one hour before induction.
control group	Placebo	21 patients will receive placepo one hour before induction.

Primary Outcome Measures

Name	Time	Method
Asessment of emergence agitation	through study completion, an average of 1 year	Asessment of emergence agitation by Richmond Agitation Sedation Scale(RASS) (score +1 or more) maximum value is +4 (combative) andminimum value is - (unarousable)

Secondary Outcome Measures

Name	Time	Method
Duration of emergence	through study completion, an average of 1 year	The time in minutes from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command
Duration of Post Anesthesia Care Unit (PACU)stay	through study completion, an average of 1 year	the time in minutes from arrival to Post Anesthesia Care Unit (PACU) to discharge to ward
Number of patients had Postoperative pain	through study completion, an average of 1 year	Postoperative pain through Numerical Rating Scale (0 represents no pain and 10 represents worst possible pain)
Number of patients required postoperative opioids and total dose.	through study completion, an average of 1 year
Number of patients had postoperative nausea and vomiting (PONV).	through study completion, an average of 1 year
1. Heart rate	through study completion, an average of 1 year	heart rate in beat per minute (bpm) will be recorded every 5 minutes till the end of operation.
systolic, diastolic and mean arterial blood pressure	through study completion, an average of 1 year	systolic, diastolic and mean arterial blood pressure in millimeter of mercury (mmHg) will be recorded every 5 minutes till the end of operation.
Oxygen saturation	through study completion, an average of 1 year	Oxygen saturation in percentage will be recorded every 5 minutes till the end of operation.
Duration of extubation	through study completion, an average of 1 year	the time in minutes from discontinuation of the anesthetic to removal of endotracheal tube

Trial Locations

Locations (1)

Kasr Elainy Hospital , Cairo University; 🇪🇬 Cairo, Egypt