Emergence Agitation
Conditions
Brief 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.
Interventions
DRUGDexmedetomidine
Patients were given dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minute prior to the procedure.
DRUGMidazolam
Patients received midazolam with a loading dose of 0.02 mg/kg in 10 min prior to the procedure.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness in emergence agitation | 90 minutes | The effectiveness of the treatment was assessed through Ricker's sedation and agitation score, with a score of 4 as efficacy 'yes'. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMadiha Ashraf
Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
STUDY_DIRECTORAmbreen Khan, FCPS
Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
Outcome results
None listed