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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Bahawalpur, Punjab Province, Pakistan, 63100
      • Bahawal Victoria Hospital/Quad-e-Azam Medical College
    • Bahawalpur, Punjab Province, Pakistan, 63100
      • Bahawal Victoria Hospital/Quid-e-Azam Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group-D; Patients were given a dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minutes prior to the procedure.	Drug: Dexmedetomidine; Patients were given dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minute prior to the procedure.
Experimental: Group-M; Patients received a midazolam injection with a loading dose of 0.02 mg/kg in 10 min prior the procedure.	Drug: Midazolam; Patients received midazolam with a loading dose of 0.02 mg/kg in 10 min prior to the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness in emergence agitation	The effectiveness of the treatment was assessed through Ricker's sedation and agitation score, with a score of 4 as efficacy 'yes'.	90 minutes

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Study Director: Ambreen Khan, FCPS, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur; Principal Investigator: Madiha Ashraf, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Benzazepines; Benzodiazepines; Midazolam; Dexmedetomidine
• Other Study ID Numbers: Dr-Madiha-BVH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

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