NCT07392983

Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Muhammad Aamir Latif · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Patients were given dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minute prior to the procedure.
DRUG	Midazolam	Patients received midazolam with a loading dose of 0.02 mg/kg in 10 min prior to the procedure.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

2 sites across 1 country: Pakistan