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

NCT06887998 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: gabapentin for agitation
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation

Keywords

emergence agitation; gabapentin; nasal surgery

Outcome Measures

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)

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Duration of emergence

  through study completion, an average of 1 year

• Duration of Post Anesthesia Care Unit (PACU)stay

  through study completion, an average of 1 year

• Number of patients had Postoperative pain

  through study completion, an average of 1 year

• 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

Study Arms (3)

Gabapentin 600 mg group

ACTIVE COMPARATOR

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

Drug: Gabapentin 600 mg capsules

Gabapentin 400 mg group

ACTIVE COMPARATOR

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

Drug: Gabapentin 400 mg capsules

control group

PLACEBO COMPARATOR

21 patients will receive placepo one hour before induction.

Drug: Placebo

Interventions

Gabapentin 600 mg capsules DRUG

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

Gabapentin 600 mg group

Gabapentin 400 mg capsules DRUG

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

Gabapentin 400 mg group

Placebo DRUG

21 patients will receive placepo one hour before induction.

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• hypersensitivity to gabapentin
• patient refusal
• epilepsy
• neurological or psychological conditions that impair communication.
• current use of gabapentin, psychotropic or opioids medications.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Elainy Hospital , Cairo University

Cairo, Cairo Governorate, 11956, Egypt

Location

Related Publications (1)

• Badawy AA, Kasem SA, Rashwan D, Al Menesy T, Adel G, Mokhtar AM, Badawy YA. The role of Gabapentin oral solution in decreasing desflurane associated emergence agitation and delirium in children after stabismus surgery, a prospective randomized double-blind study. BMC Anesthesiol. 2018 Jun 20;18(1):73. doi: 10.1186/s12871-018-0533-5.

  PMID: 29925328 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

maged mobarak mobarak, assisstant lecturer

CONTACT

+0201010282650; magedmubark98@gmail.com

Hebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU

CONTACT

+201004507530; drhebasalah593@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will be randomly allocated (using sealed opaque numbered envelopes indicating the group of each patient, carried out by an independent anesthesiologist) into one of three groups : * Group (A) \[n = 21 patients\]: will receive 600 mg oral gabapentin one hour before induction. * Group(B) \[n =21 patients \]:will receive 400 mg oral gabapentin one hour before induction. * Group (C) (control group) \[n =21 patients \] : will receive placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: March 21, 2025
• Study Start: March 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-02

Locations

EG (1)