A randomized control trial to compare the efficacy of dexmedetomidine and labetalol for induced hypotensive anaesthesia in ear, nose and throat surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- To compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients of either sex undergoing elective ENT surgeries under general anaesthesia
- •American Society of Anaesthesiologists I or II
- •BMI between 18.5 and 24.9 kg/m2.
Exclusion Criteria
- •American Society of Anaesthesiologists III and above
- •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.
Outcomes
Primary Outcomes
To compare the effectiveness of dexmedetomidine and labetalol to induce controlled hypotension of 20-30% reduction in mean arterial pressure from the baseline.
Time Frame: Intraoperative Period
Secondary Outcomes
- 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)