A study to compare the how good is dexmedetomidine and labetalol for providing reduced blood pressure during anaesthesia for surgeries of ear, nose and throat.

Not yet recruiting

• Conditions: Disease of upper respiratory tract, unspecified, (2) ICD-10 Condition: H952||Intraoperative hemorrhage and hematoma of ear and mastoid process complicating a procedure,

• Registration Number: CTRI/2019/03/018007
• Lead Sponsor: Robin Sajan Chacko

Brief Summary

This is a randomized controlled trial to compare the efficacy of dexmedetomidine and labetalol for producing induced hypotensive anaesthesia in 58 patients posted for ear nose throat surgeries over a period of 18 months. The primary outcome would be to compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline. The secondary objectives are to compare surgeon’s satisfaction of surgical field between the study drugs, to compare total blood loss occurring during surgery between the study drugs and to compare recovery time between the study drugs.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-07-03
• Study Start: 2019-12-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• 1.Patients of either sex undergoing elective ENT surgeries under general anaesthesia 2.
• American Society of Anaesthesiologists I or II 3.
• BMI between 18.5 and 24.9 kg/m2.

Exclusion Criteria

• American Society of Anaesthesiologists III and above 2.
• Allergic to study drugs.
• Asthmatic patients.
• Patients having coagulopathy.
• Patients with heart blocks.
• Lactating mothers and pregnant patients.
• Hepatic or renal abnormality.
• Patients with congestive cardiac failure, bradycardia.
• Hypertensive patients.
• Patients using beta blockers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline.	Intraoperative Period

Secondary Outcome Measures

Name	Time	Method
To compare surgeon’s satisfaction of surgical field between the study drugs.	Intraoperative period
To compare total blood loss occurring during surgery between the study drugs.	Intraoperative period
To compare recovery time between the study drugs.	Postoperative period

Trial Locations

Locations (1)

Shri Sathya Sai Medical College and Research Institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Shri Sathya Sai Medical College and Research Institute

🇮🇳Kancheepuram, TAMIL NADU, India

Robin Sajan Chacko

Principal investigator

9496140000

robinsajan@hotmail.com