Summary of Study: Comparison of the Effect of Dexmedetomidine and Magnesium Sulphate in Controlled Hypotension During Functional Endoscopic Sinus Surgery

Study Title:

Comparison of the Effect of Dexmedetomidine and Magnesium Sulphate in Controlled Hypotension During Functional Endoscopic Sinus Surgery

Aims and Objectives:

The study aims to compare the effects of dexmedetomidine and magnesium sulfate in controlling hypotension during functional endoscopic sinus surgery (FESS). The primary goal is to assess their efficacy in controlling blood pressure and maintaining optimal surgical conditions.

Study Centre:

The study will be conducted at Gajra Raja Medical College & JAH Group of Hospitals, Gwalior.

Duration of the Study:

The study will take place from May 2023 to October 2024.

Introduction:

As detailed in the submitted synopsis, controlled hypotension during FESS is crucial for better visibility and improved surgical outcomes. Both dexmedetomidine and magnesium sulfate have been investigated for their role in controlling intraoperative blood pressure while minimizing adverse effects.

Study Design:

Prospective comparative study to compare the efficacy and safety of dexmedetomidine and magnesium sulfate in controlling hypotension during FESS.

Methodology (Materials & Methods):

The methodology, as outlined in the submitted synopsis, includes a controlled study where patients undergoing FESS will be administered either dexmedetomidine or magnesium sulfate. Hemodynamic parameters, surgical conditions, and complications will be monitored and recorded.

Inclusion Criteria:

As mentioned in the submitted synopsis, the study will include adult patients scheduled for FESS who meet the specific health requirements outlined in the inclusion criteria.

Exclusion Criteria:

Exclusion criteria, as mentioned in the synopsis, include patients with contraindications to dexmedetomidine or magnesium sulfate, those with significant cardiovascular or renal disease, or patients with allergies to study medications.

Sample Size:

The study will include 70 patients, based on statistical power calculations for comparison between the two drugs.

Procedure Planned:

As mentioned in the synopsis, FESS will be performed under general anesthesia with controlled hypotension induced using either dexmedetomidine or magnesium sulfate.

Investigation Details:

The investigation will involve continuous monitoring of hemodynamic parameters, such as mean arterial pressure (MAP), heart rate, and oxygen saturation, to assess the effects of each drug.

Data Collection and Methods:

Data will be collected on blood pressure, heart rate, respiratory rate, and surgical outcomes. Patient satisfaction, recovery times, and any adverse events will also be documented.

Statistical Analysis Plan:

Data will be analyzed using SPSS Software 22.0. Statistical tests, including t-tests or chi-square tests, will be used to compare the outcomes between the two groups. A p-value of <0.05 will be considered statistically significant.