Emergence AgitationPhase 3NCT06887998
The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.
A Phase 3 study testing Gabapentin 600 mg capsules and Gabapentin 400 mg capsules in people with Emergence Agitation, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Gabapentin 600 mg capsules and Gabapentin 400 mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- hypersensitivity to gabapentin
- patient refusal
- epilepsy
- neurological or psychological conditions that impair communication.
- current use of gabapentin, psychotropic or opioids medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU contact
Egypt1 site
Kasr Elainy Hospital , Cairo University
Cairo, Cairo Governorate, 11956
vice dean for community affairs, +20223647545, website@kasralainy.edu.eg
maged mobarak abdelkhalek, assistant lecturer of
About this study
Official title: 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.
Read more
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
- Being tested
- Gabapentin 600 mg capsules, Gabapentin 400 mg capsules, Placebo
- Keywords
- emergence agitation, gabapentin, nasal surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 600 mg capsulesDrug
21 patients will receive 600 mg oral gabapentin one hour before induction.
Gabapentin 400 mg capsulesDrug
21 patients will receive 400 mg oral gabapentin one hour before induction.
PlaceboDrug
21 patients will receive placepo one hour before induction.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin 600 mg group | Active comparator | 21 patients will receive 600 mg oral gabapentin one hour before induction. Receives: Drug: Gabapentin 600 mg capsules |
| Gabapentin 400 mg group | Active comparator | 21 patients will receive 400 mg oral gabapentin one hour before induction. Receives: Drug: Gabapentin 400 mg capsules |
| control group | Placebo comparator | 21 patients will receive placepo one hour before induction. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Duration of emergence
The time in minutes from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command
Measured: through study completion, an average of 1 year
Duration of Post Anesthesia Care Unit (PACU)stay
the time in minutes from arrival to Post Anesthesia Care Unit (PACU) to discharge to ward
Measured: through study completion, an average of 1 year
Number of patients had Postoperative pain
Postoperative pain through Numerical Rating Scale (0 represents no pain and 10 represents worst possible pain)
Measured: through study completion, an average of 1 year
Number of patients required postoperative opioids and total dose.
Measured: through study completion, an average of 1 year
Number of patients had postoperative nausea and vomiting (PONV).
Measured: through study completion, an average of 1 year
1. Heart rate
heart rate in beat per minute (bpm) will be recorded every 5 minutes till the end of operation.
Measured: through study completion, an average of 1 year
systolic, diastolic and mean arterial blood pressure
systolic, diastolic and mean arterial blood pressure in millimeter of mercury (mmHg) will be recorded every 5 minutes till the end of operation.
Measured: through study completion, an average of 1 year
Oxygen saturation
Oxygen saturation in percentage will be recorded every 5 minutes till the end of operation.
Measured: through study completion, an average of 1 year
Duration of extubation
the time in minutes from discontinuation of the anesthetic to removal of endotracheal tube
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Mobarak Abdelkhalek Abdelfattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887998
- Sponsor's protocol ID
- gabapentin for agitation
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29925328
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06887998
- Acronym / sponsor ID
- gabapentin for agitation
- Conditions
- Emergence Agitation
- Keywords
- emergence agitation, gabapentin, nasal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gabapentin 600 mg group | Active comparator | Drug: Gabapentin 600 mg capsules21 patients will receive 600 mg oral gabapentin one hour before induction. |
| Gabapentin 400 mg group | Active comparator | Drug: Gabapentin 400 mg capsules21 patients will receive 400 mg oral gabapentin one hour before induction. |
| control group | Placebo comparator | Drug: Placebo21 patients will receive placepo one hour before induction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- hypersensitivity to gabapentin
- patient refusal
- epilepsy
- neurological or psychological conditions that impair communication.
- current use of gabapentin, psychotropic or opioids medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin 600 mg capsules21 patients will receive 600 mg oral gabapentin one hour before induction. | Drug | Gabapentin 600 mg group |
| Gabapentin 400 mg capsules21 patients will receive 400 mg oral gabapentin one hour before induction. | Drug | Gabapentin 400 mg group |
| Placebo21 patients will receive placepo one hour before induction. | Drug | control group |
Primary outcome
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)
9 secondary outcomes
Duration of emergence
Time frame: 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
Number of patients had Postoperative pain
Time frame: 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
Number of patients had postoperative nausea and vomiting (PONV).
Time frame: through study completion, an average of 1 year
1. Heart rate
Time frame: 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
Oxygen saturation
Time frame: through study completion, an average of 1 year
Duration of extubation
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 29925328Badawy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin 600 mg capsules and Gabapentin 400 mg capsules in people with Emergence Agitation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact maged mobarak mobarak, assisstant lecturer (+0201010282650, magedmubark98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asessment of emergence agitation (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.