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Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

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ClinicalTrials.gov Identifier: NCT03809065
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Heba Nassar,MD, Cairo University

Brief Summary:
Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery; however, hypotension might impair perfusion of vital organs. The aim of this work is to compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for induction of deliberate hypotension

Condition or disease Intervention/treatment Phase
Tissue Perfusion Deliberate Hypotension Sinus Endoscopic Surgery Drug: Nitroglycerin Drug: Labetalol Phase 4

Detailed Description:
Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the status of peripheral perfusion under this target is not well investigated. Nitroglycerin and Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a direct vasodilator and its main action is through venodilation, while labetalol combines a selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously compared during deliberate hypotension with regard to surgical field quality and blood loss. No study to date compared the effects of both drugs on peripheral perfusion when used for induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin and labetalol on tissue perfusion when used for induction of deliberate hypotension during FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of peripheral and global tissue perfusion respectively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.
Actual Study Start Date : January 19, 2019
Actual Primary Completion Date : May 25, 2019
Actual Study Completion Date : May 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: group N
Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .
Drug: Nitroglycerin
Nitroglycerin is a direct vasodilator and its main action is through venodilation. Nitroglycerin will be diluted by adding 3 mL (3 mg) to 47 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr to have a starting dose of 0.5 μg/Kg/min. The rate of nitroglycerin infusion will be 0.5-2 μg /kg/min .The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.

Active Comparator: group L
Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
Drug: Labetalol
Labetalol is an α and β - adrenergic receptors competitive antagonist. Labetalol will be diluted by adding 10 mL (50 mg) to 40 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr. The rate of Labetalol infusion will be 0.5-2 mg/kg/h.The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.




Primary Outcome Measures :
  1. Peripheral perfusion index [ Time Frame: 4 hours ]
    Peripheral perfusion index will be used as a marker of peripheral perfusion.


Secondary Outcome Measures :
  1. Change in serum lactate concentration [ Time Frame: Immediately before induction of anesthesia and after 60 minutes post recovery. ]
    Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.

  2. Total blood loss [ Time Frame: from beginning of surgery till the end of the procedure ]
    Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.

  3. Surgical field score (SFS) [ Time Frame: from beginning of surgery till the end of the procedure. ]

    SFS ranges from 0 to 5 as follows: 0: No bleeding, 1: Slight bleeding-no suctioning of blood required, 2: Slight bleeding-occasional suctioning required. Surgical field not threatened. 3: Slight bleeding-frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed, 4: Moderate bleeding-frequent suctioning required. Bleeding threatens surgical field directly after suction is removed, 5: Severe bleeding-constant suctioning required. Bleeding appears faster that can be removed by suction. Surgical field severely threatened and surgery not possible.

    Adequate surgical field is defined as SFS <3


  4. Mean arterial blood pressure [ Time Frame: 4 hours ]
    Target mean arterial pressure during deliberate hypotension will be 55-65mmHg

  5. Heart rate [ Time Frame: 4 hours ]
    Number of heart beats per minute



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female patients
  • 18-45 years
  • ASA physical status I-II
  • scheduled for FESS operations

Exclusion Criteria:

  • uncontrolled hypertension
  • cerebrovascular disorders
  • coagulation disorders
  • cardiovascular diseases
  • renal impairment
  • liver impairment
  • history of allergic reaction to any of the study medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809065


Locations
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Egypt
Kasr Al Ainy
Cairo, Egypt, 11562
Sponsors and Collaborators
Cairo University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heba Nassar,MD, Associate professor of Anesthesia, Cairo University
ClinicalTrials.gov Identifier: NCT03809065    
Other Study ID Numbers: N53-2016
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heba Nassar,MD, Cairo University:
Deliberate hypotension
Nitroglycerin
Labetalol
Peripheral perfusion
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Labetalol
Nitroglycerin
Vasodilator Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists