Ear, Nose and Throat Procedure, Hypotensive Anesthesia
Conditions
Keywords
Hypotensive anesthesia, Labetalol, Dexmedetomidine
Brief summary
this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
Detailed description
Hypotensive anaesthesia is the deliberate lowering of a patient's blood pressure during surgery. It is necessary during ear, nose and throat surgery for drying surgical field, ease in operation procedure and shortening of the duration of surgery. Labetalol is a unique parenteral anti-hypertensive drug that has selective α1 and non- selective β adrenergic antagonist effects. In humans, the β to α blocking potency ratio is 7: 1 for IV labetalol. Dexmedetomidine is highly selective alpha2 adrenergic agonist having several beneficial actions during the perioperative period. Activation of alpha2 adrenergic receptors in the brain and spinal cord inhibits neuronal firing causing hypotension and bradycardia. This study was designed to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
Interventions
DRUGHypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions
The study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
data collector is also masked in the clinical trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists I, II (ASA I, II) patients who were candidate for Ear, Nose and Throat surgeries. * Age: between 20 and 50 years
Exclusion criteria
* Patients with uncontrolled hypertension, variable degrees of heart block, congestive cardiac failure, coagulopathy, cerebral insufficiency, hepatic or renal abnormality * Patients on beta blocker or clonidine * Pregnant or lactating females * Patients who were allergic to any of the anesthetic or hypotensive drugs used in the study * Patient refusal to be included in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate changes before induction of anesthesia and every 15 min | 12 months |
| Surgical site oligaemia will be evaluated by the surgeons by rating the amount of bleeding according to Modena bleeding score that provides five different levels (from Grade 1 - no bleeding to Grade 5) | 12 months |
| Surgeon satisfaction At the end of the surgery will be evaluated by one surgeon and recorded according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor) | 12 months |
| Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption. | 12 months |
Countries
Egypt
Contacts
Primary ContactNourhan Osama, Master degree
Outcome results
None listed