Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

Ain Shams University153 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

153

Conditions

Anesthesia

Interventions

DexmedetomidineDRUG

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

GabapentinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

faculty of medicine, Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

emergence agitation (EA)

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

Time frame: During first hour of recovery.

Secondary Outcomes

Postoperative pain in the form of visual analog scale

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

Time frame: every 4 hours for 12 hours

Incidence of the common adverse effects

nausea and vomiting, dizziness, and headache

Time frame: at 12 hours

Data from ClinicalTrials.gov

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