Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05626998
• Other study ID #: FMASU R 164/ 2022
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia
• Emergence Delirium

Intervention

Drug:
• Dexmedetomidine
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

Locations

Country	Name	City	State
Egypt	faculty of medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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