Comparing the operation site visibility in Inner Nose surgery using a camera, while using two different medicines : Lignocaine ( a local Anesthesia drug) and Dexmeditomidine ( a sedative drug)

Not yet recruiting

• Conditions: Chronic sinusitis,

• Registration Number: CTRI/2022/10/046143
• Lead Sponsor: Dr Pughal vendan G

Brief Summary

This study is a randomised, double blinded, parallel group, single centre trial comparing the effect of intraoperative infusion of Lignocaine 1.5 mg/kg/min and Dexmedetomidine 0.5 mcg/kg/min infusion in Functional endoscopic sinus surgeries. The primary outcome will be surgical field quality assessed every 15 min during the surgery using Fromme et al  score. **Score 0** - No bledding in Nasopharynx; **Score 1** - slight bleeding, no suctioning required; **Score 2 -**Bleeding requiring occasional suctioning; **Score 3**- frequent suctioning; **Score 4** - Moderate bleeding, frequent suctioning; **Score 5** - severe bleeding, constant suctioning required. Secondary outcome of the study will be the Hemodyanic variability, Blood pressure and Heart rate at baseline and every 15 min since start of surgery will recorded and compared.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-10
• Study Start: 2022-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Adult patients posted for Endoscopic Sinus surgery, FESS ASA physical status 1 and 2 patients.

Exclusion Criteria

ASA PS 3 and above Uncontrolled hypertension Patients with heart block Patients on home beta blocker therapy Known cerebrospinal vascular accident Obesity BMI >35 Hepatic and renal insufficiency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Better surgical field quality which helps in successful surgical outcome	Surgical field quality will assessed by a visual scale suggested by Fromme et al every 15 min during the surgery

Secondary Outcome Measures

Name	Time	Method
Hemodynamic variability : Systolic Blood pressure SBP, Diastolic Blood pressure DBP, Mean Arterial pressure MAP, Heart rate HR	Baseline,

Trial Locations

Locations (1)

Sri Muthukumaran Medical college Hospital and research institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Sri Muthukumaran Medical college Hospital and research institute

🇮🇳Kancheepuram, TAMIL NADU, India

Dr G Pughal Vendan

Principal investigator

8610016102

drpughalvendan@gmail.com