comparison between intravenous dexmedetomidine and magnesium sulphate in producing hypotensive anesthesia in patients undergoing Functional endoscopic sinus surgeries

Phase 4

Not yet recruiting

• Conditions: Chronic sinusitis, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2024/05/068035
• Lead Sponsor: Arupadai veedu medical college and hospital

Brief Summary

Endoscopic sinus surgeries are the most proposed procedure for patients with chronic Rhinosinusitis. Due to the nature of the site involved in surgery, a small amount of bleeding can cause negative effect on the procedure by affecting the proper visualization of the surgical field causing difficulty in doing surgery & prolonged duration of the surgery. So controlled hypotension will help in proper visualization of surgical field and minimize the blood loss. so we are comparing dexmedetomidine and magnesium sulphate in producing controlled hypotension.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-28
• Study Start: 2024-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• ASA-physical status I and II.
• patients undergoing Functional Endoscopic Sinus Surgeries.

Exclusion Criteria

• Patient refusal.
• Patients with severe cardiac hepatic renal disease.
• Patients with a history of drug allergy to the study drugs.
• Patients with hemodynamic instability.
• Patients with coagulopathies.
• Pregnant patients.
• Patients with autonomic dysfunction.
• Patients with Anti-arrhythmic drugs & Anti-hypertensive drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of Dexmedetomidine vs Magnesium sulphate in providing controlled hypotension during Functional Endoscopic Sinus Surgeries. By means of monitoring MAP mean arterial pressure throughout the procedure.	2 hours

Secondary Outcome Measures

Name	Time	Method
To assess the surgeons satisfaction during procedure Likert score	2 hours
Time to reach adequate Modified Aldrete score	20 minutes
To assess the level of bleeding during procedure Boezaart & Van der merwe score.
Clinical signs related to study drugs	2 hours
To assess the level of sedation of the patient post operatively Ramsay Sedation Score.	2 hours
Time of Requirement of 1st rescue analgesia VAS score.	2 hours

Trial Locations

Locations (1)

Aarupadai veedu medical college and hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Aarupadai veedu medical college and hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr senthil bharath s

Principal investigator

8098908559

senthilbharathdrssb@gmail.com