Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Dexmedetomidine; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05626998

FMASU R 164/ 2022

Details and patient eligibility

About

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

Full description

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.

Enrollment: 153 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 3 patient groups

Control

No Intervention group

Description:

The participants will not receive premedication

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Gabapentin

Active Comparator group

Description:

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

Treatment:

Drug: Gabapentin