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Completed

NCT Number: NCT05626998

Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.

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Key information

Conditions

Anesthesia

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

About this study

Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for EA.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiologists grade I or II.
  • Sex: Both sexes.
  • Age between 18 and 40 years.
  • Patients scheduled for rhinoplasty under general anesthesia

Exclusion criteria

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • history of cardiovascular diseases including bradycardia, heart block, and hypertension.
  • History of chest problems including bronchial asthma.
  • Had a history of drug or alcohol abuse.
  • Taking opioids or sedative medications.
  • Inability to communicate with patients to evaluate postoperative pain.
  • Hepatic or renal failure.
  • Psychiatric disorders with antipsychotics or antidepressants.
  • Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).

Treatment and study plan

Dexmedetomidine

Drug

The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.

Gabapentin

Drug

The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward

Primary outcomes

  1. emergence agitation (EA)

    Time frame: During first hour of recovery.

    in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).

Secondary outcomes

  1. Postoperative pain in the form of visual analog scale

    Time frame: every 4 hours for 12 hours

    (VAS, 0=no pain; 10=worst possible pain)

  2. Incidence of the common adverse effects

    Time frame: at 12 hours

    nausea and vomiting, dizziness, and headache

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2022
Registry last updated
Aug 30, 2023

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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