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Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia

NCT ID: NCT06752863

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Hypotensive Anesthesia Ear, Nose and Throat Procedure

Keywords

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Hypotensive anesthesia Labetalol Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
data collector is also masked in the clinical trial

Study Groups

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Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion

Dexmedetomidine group: the patients will receive deliberate hypotensive anesthesia with dexmedetomidine infusion (precedex ® 200 μg/2 ml; Hospira, Inc., Rocky Mount, USA) via syringe pump by adding 200 mcg (2ml) of dexmedetomidine to 48 ml of normal saline (final concentration of 4 mcg/ml) The patients will receive a loading dose of 1mcg/kg intravenously followed by an infusion of 0.7 mcg/kg/hour as maintenance dose.

Group Type ACTIVE_COMPARATOR

Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions

Intervention Type DRUG

The study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries

Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion

Labetalol groups: the patients will receive deliberate hypotensive anesthesia with labetalol infusion (Labipress 100mg/20ml; Al Debeiky pharma(DBK) pharmaceutical co., Cairo, Egypt) via syringe pump by adding 100 mg (20ml) of Labetalol to 30ml of normal saline (final concentration of 2 mg/ml) The patients will receive a loading dose of 0.4mg/kg intravenously followed by an infusion of 0.04mg/kg/hour as maintenance dose.

Group Type ACTIVE_COMPARATOR

Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions

Intervention Type DRUG

The study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries

Interventions

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Hypotensive 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams university

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nourhan Osama, Master degree

Role: CONTACT

Phone: 002 01064764758

Email: [email protected]

Facility Contacts

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Nourhan Osama, Master degree

Role: primary

Other Identifiers

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FMASU MD105/2024

Identifier Type: -

Identifier Source: org_study_id