Health TrialsbyHealthPanel

Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia

ConditionsHypotensive AnesthesiaEar, Nose and Throat Procedure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-50
SponsorAin Shams University

About this trial

this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusionActive comparator 1 intervention
Group B: Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension

Time frame
12 months

Secondary outcomes

1

Heart rate changes before induction of anesthesia and every 15 min

Time frame
12 months
2

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")

Time frame
12 months
3

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)

Time frame
12 months
4

Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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