Clinical trial NCT06752863: Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia
Official title: Comparative Study of Labetalol Infusion Versus Dexmedetomidine Infusion in Hypotensive Anesthesia in Ear, Nose and Throat Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypotensive Anesthesia
Ear, Nose and Throat Procedure
Keywords: Hypotensive anesthesia
Labetalol
Dexmedetomidine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension
timeFrame: 12 months
Secondary outcomes:
measure: Heart rate changes before induction of anesthesia and every 15 min
timeFrame: 12 months
measure: 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")
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption.
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
References: