Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

The participants will not receive premedication

Group Type NO_INTERVENTION

No interventions assigned to this group

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Gabapentin

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

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Gabapentin

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes