Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Gabapentin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: tamer S abdelaziz, MD; Phone Number: +201154601505; Email: drtasamir@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The participants will not receive premedication
Active Comparator: Dexmedetomidine; The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward	Drug: Dexmedetomidine; The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.
Active Comparator: Gabapentin; The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward	Drug: Gabapentin; The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergence agitation (EA)	in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).	During first hour of recovery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain in the form of visual analog scale	(VAS, 0=no pain; 10=worst possible pain)	every 4 hours for 12 hours
Incidence of the common adverse effects	nausea and vomiting, dizziness, and headache	at 12 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: tamer S abdelaziz, MD, Faculty of medicine, Ain Shams University, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Dexmedetomidine; Gabapentin
• Other Study ID Numbers: FMASU R 164/ 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No