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

March 19, 2025 updated by: Maged Mobarak Abdelkhalek Abdelfattah, Cairo University

The Effect of Two Different Doses of Oral Gabapentin on Sevoflurane-associated Emergence Agitation and Delirium in Adult Patients After Nasal Surgery. a Prospective Controlled, Randomized, Double-blinded Study.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

63

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU
  • Phone Number: +201004507530
  • Email: drhebasalah593@gmail.com

Study Locations

  • Egypt
      • Cairo, Egypt, 11956
        • Kasr Elainy Hospital , Cairo University
        • Contact:
        • Contact:
          • maged mobarak abdelkhalek, assistant lecturer of
        • Contact:
          • Ahmed Ali Badawy, professor of anesthesia
        • Contact:
          • Ashraf Abdelmwgod Ali, professor of anesthesia
        • Contact:
          • ahmed farag mohamed, lrcturer
        • Contact:
          • hebatalla salah abdelhamid, lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gabapentin 600 mg group
21 patients will receive 600 mg oral gabapentin one hour before induction.
Drug: Gabapentin 600 mg capsules
21 patients will receive 600 mg oral gabapentin one hour before induction.
Active Comparator: Gabapentin 400 mg group
21 patients will receive 400 mg oral gabapentin one hour before induction.
Drug: Gabapentin 400 mg capsules
21 patients will receive 400 mg oral gabapentin one hour before induction.
Placebo Comparator: control group
21 patients will receive placepo one hour before induction.
Drug: Placebo
21 patients will receive placepo one hour before induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asessment of emergence agitation
Time Frame: 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)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of emergence
Time Frame: 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
through study completion, an average of 1 year
Duration of Post Anesthesia Care Unit (PACU)stay
Time Frame: through study completion, an average of 1 year
the time in minutes from arrival to Post Anesthesia Care Unit (PACU) to discharge to ward
through study completion, an average of 1 year
Number of patients had Postoperative pain
Time Frame: through study completion, an average of 1 year
Postoperative pain through Numerical Rating Scale (0 represents no pain and 10 represents worst possible pain)
through study completion, an average of 1 year
Number of patients required postoperative opioids and total dose.
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Number of patients had postoperative nausea and vomiting (PONV).
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
1. Heart rate
Time Frame: 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.
through study completion, an average of 1 year
systolic, diastolic and mean arterial blood pressure
Time Frame: 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.
through study completion, an average of 1 year
Oxygen saturation
Time Frame: through study completion, an average of 1 year
Oxygen saturation in percentage will be recorded every 5 minutes till the end of operation.
through study completion, an average of 1 year
Duration of extubation
Time Frame: through study completion, an average of 1 year
the time in minutes from discontinuation of the anesthetic to removal of endotracheal tube
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gabapentin for agitation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Emergence Agitation

Clinical Trials on Gabapentin 600 mg capsules

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe