Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation

Since the frequency of emergence agitation (EA) is relatively high in children while undergoing nasal surgery, and there is not much data available in Pakistan regarding EA in adults undergoing functional endoscopic sinus surgery (FESS). Hence there is a need to conduct this study in the local population to see the effect of dexmedetomidine and midazolam on EA. Therefore, the current study was initiated, aiming to compare the effect of dexmedetomidine and midazolam on EA in patients undergoing FESS.

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Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahawal Victoria Hospital/Quad-e-Azam Medical College, Bahawalpur, Punjab Province, Pakistan

About this study

There is not much local data present on the topic of EA. As the frequency of EA is relatively high, it can lead to any unwanted event, which can lead to other complications in the patients undergoing nasal surgery. Although in some studies dexmedetomidine has been found to significantly reduce the frequency of EA and severity, provide better sedation, and lower the need for postoperative rescue analgesia in patients undergoing FESS, few others have claimed comparable results for midazolam as well. The findings of this study would not only add to the local data but also be helpful in determining a better option in reducing the frequency of this phenomenon in patients undergoing FESS under general anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any gender
Aged 16-60 years
Undergoing elective FESS under general anesthesia

Exclusion criteria

Patients with the presence of infection at the site of the blockage
Epilepsy, myasthenia gravis, or polio (as per history and clinical record)
Systemic illness (such as cardiac, hepatic, endocrinal or neurological)
Substance induced disorder
Psychiatric disorders
Taking medications, such as alpha 2 agonists, beta blockers' or tricyclic anti-depressants
Allergies to the medications used

Treatment and study plan

Dexmedetomidine

Drug

Patients were given dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minute prior to the procedure.

midazolam

Drug

Patients received midazolam with a loading dose of 0.02 mg/kg in 10 min prior to the procedure.

Primary outcomes

Effectiveness in emergence agitation

Time frame: 90 minutes

The effectiveness of the treatment was assessed through Ricker's sedation and agitation score, with a score of 4 as efficacy 'yes'.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 6, 2026
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed