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Tissue PerfusionPhase 4NCT03809065

Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

A Phase 4 study testing Nitroglycerin and Labetalol in people with Tissue Perfusion and Deliberate Hypotension, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Nitroglycerin and Labetalol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
19 Jan 2019to 25 May 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kasr Al Ainy

    Cairo, 11562

Other trials in Egypt

About this study

Official title: Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.

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

Read the 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.

Being tested
Nitroglycerin, Labetalol
Keywords
Deliberate hypotension, Nitroglycerin, Labetalol, Peripheral perfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NitroglycerinDrug

    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}.

  • LabetalolDrug

    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}.

Study groups in NCT03809065
Study groupRoleWhat they receive
group NExperimentalPatients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .
Receives: Drug: Nitroglycerin
group LActive comparatorPatients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
Receives: Drug: Labetalol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral perfusion index

    Peripheral perfusion index will be used as a marker of peripheral perfusion.

    Measured: 4 hours

Secondary outcomes (5)

  1. Change in serum lactate concentration

    Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.

    Measured: Immediately before induction of anesthesia and after 60 minutes post recovery.

  2. Total blood loss

    Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.

    Measured: from beginning of surgery till the end of the procedure

  3. Surgical field score (SFS)

    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

    Measured: from beginning of surgery till the end of the procedure.

  4. Mean arterial blood pressure

    Target mean arterial pressure during deliberate hypotension will be 55-65mmHg

    Measured: 4 hours

  5. Heart rate

    Number of heart beats per minute

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start19 Jan 2019
  3. Primary completion25 May 2019
  4. Study completion25 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809065
Sponsor's protocol ID
N53-2016
Status last verified
Apr 2020
First submitted
13 Jan 2019
Last updated
27 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zayed M, Nassar H, Hasanin A, Saleh AH, Hassan P, Saad D, Mahmoud S, Abo Bakr G, Fouad E, Saleh N, Ismail M, El-Hadi H. Effects of nitroglycerin versus labetalol on peripheral perfusion during deliberate hypotension for sinus endoscopic surgery: a randomized, controlled, double-blinded trial. BMC Anesthesiol. 2020 Apr 17;20(1):85. doi: 10.1186/s12871-020-01006-w.

    PubMed 32303182

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nitroglycerin and Labetalol in people with Tissue Perfusion and Deliberate Hypotension, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral perfusion index (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

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