Comparison of intranasal versus intravenous dexmedetomidine efficacy in quality of surgical field visualization in functional endoscopic sinus surgery a prospective randomized controlled clinical study

Title -  “Comparison of intranasal versus intravenous dexmedetomidine efficacy in quality of surgical field visualization in functional endoscopic sinus surgery: a prospective, randomized controlled clinical study”

-  Dr. Dasari Subha Priyanka

 OBJECTIVES:

Primary Objective:

1.To assess the quality of surgical field visualization in intravenous and intranasal administration of dexmedetomidine in functional endoscopic sinus surgery.

Secondary objectives:

1.To assess the effect on intraoperative hemodynamics.

2.To assess the effect on emergence time.

3.To study incidence of adverse effects like hypotension, bradycardia, shivering and postoperative nausea vomiting.

JUSTIFICATION:

Randomized trials directly comparing the efficacy of intranasal and intravenous dexmedetomidine in enhancing the quality of the surgical field and hemodynamic parameters during functional endoscopic sinus surgery are currently not available. Hence, this study has been designed.

 METHODOLOGY:

1. Study design: A prospective Randomized control, double blind clinical study**.**

2. Study duration: The study would be conducted over a period of one and half years after obtaining approval.

3. Study setting: Operation room AIIMS Raipur.

4 .Study population: Patients scheduled for elective functional endoscopic sinus surgery under general anaesthesia.

5. Sample size - Calculated sample size – 80

Case – 40 , Control – 40

6. Plan of work –

Two randomly divided groups – who will be undergoing elective functional endoscopic sinus surgery

Group IN – who will receive intranasal dexmedetomidine

Group IV – who will receive IV dexmedetomidine

Neither the person administering the medication nor the patients will be informed of their group assignment during the course of the study.

 Â·       Data will be collected - Demographic parameters: Age, gender, ASA physical status, duration of surgery,

·      HR, BP(MAP), RR, SPO2.

 Intraop Baseline BP, Spo2 ,HR will be measured following every 10 min this parameters will be recorded in both the groups .

The visibility of the operative field will be assessed by the surgeon according to the scale proposed by the Fromme and Boezaart in which the amount of bleed will be measured in scores .

 All information will be collected in Excel sheet and analysed in  SPSS-21.

Expected outcome: Intranasal administration of dexmedetomidine leads to better quality of surgical field and hemodynamic parameters than intravenous administration of dexmedetomidine in functional endoscopic sinus surgery.