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NCT Number: NCT06887998

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Elainy Hospital , Cairo University

Cairo, Cairo Governorate, 11956, Egypt

Location contact

Ahmed Ali Badawy, professor of anesthesia

PRINCIPAL_INVESTIGATOR

Ashraf Abdelmwgod Ali, professor of anesthesia

SUB_INVESTIGATOR

ahmed farag mohamed, lrcturer

SUB_INVESTIGATOR

hebatalla salah abdelhamid, lecturer

SUB_INVESTIGATOR

maged mobarak abdelkhalek, assistant lecturer of

SUB_INVESTIGATOR

vice dean for community affairs

CONTACT

[email protected]

+20223647545

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. Number of patients required postoperative opioids and total dose.

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

  5. Number of patients had postoperative nausea and vomiting (PONV).

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

  6. 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.

  7. 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.

  8. 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.

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU

CONTACT

[email protected]

+201004507530

maged mobarak mobarak, assisstant lecturer

CONTACT

[email protected]

+0201010282650

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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