Chronic SinusitisPhase 2NCT03661346

Esmolol vs. Labetalol in Endoscopic Sinus Surgery

A Phase 2 study testing Labetalol and Esmolol in people with Chronic Sinusitis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Sinusitis
What is being tested?: Labetalol and Esmolol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2017to 30 Mar 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of CRS with or without nasal polyps
Undergoing FESS for CRS
American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease).

Who cannot join

Pregnancy
Asthma
COPD
Bradycardia
Heart failure
End stage renal disease

Show all 10Show fewer

Cerebrovascular accident
Diabetes mellitus
Preoperative use of NSAIDs, aspirin, or beta-blockers
Body mass index (BMI) greater than 40 kg/m2.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Medical Branch
Galveston, Texas, 77550

Other trials in United States

About this study

Official title: Blood Loss and Visibility With Esmolol vs. Labetalol in Endoscopic Sinus Surgery: A Randomized Trial

The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.

Read the detailed description

BACKGROUND: Improved intraoperative visibility during functional endoscopic sinus surgery (FESS) decreases the risk of serious orbital or skull base injuries. Beta blockers are among several methods used to reduce mean arterial pressure (MAP), heart rate (HR) and mucosal bleeding. Labetalol (mixed alpha-1-beta blocker) reduces HR and MAP; however, its alpha-1 blockade may mitigate topical epinephrine decongestant effects. Esmolol (selective beta-1 blocker) does not have direct antagonistic effects on topical epinephrine. This study compares the hemodynamic parameters (rate of blood loss, MAP control, HR) and intraoperative visibility during FESS between esmolol and labetalol.

Conditions: Chronic Sinusitis
Being tested: Labetalol, Esmolol

What participants receive

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

LabetalolDrug
Aliquots of 20mg of Labetol
- Maximum Dose - 300mg total for case
EsmololDrug
Infusion - 0.1mg/kg/min
- Maximum Dose - after 30 minutes, 0.3mg/kg/min

Study groups in NCT03661346
Study group	Role	What they receive
Esmolol	Experimental	Patients receiving esmolol when intra-operative MAP > 80 mmHg. Receives: Drug: Esmolol
Labetalol	Active comparator	Patients receiving labetalol when intra-operative MAP > 80 mmHg Receives: Drug: Labetalol

What is being measured

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

Intra-operative Surgical Visibility - Boezaart Scale
Standardized scoring systems used by surgeons to rate surgical field quality in FESS:
Boezaart scale (0-5):
0 = no bleeding (optimal)
1. = slight bleeding with no suction required
2. = slight bleeding with occasional suctioning required
3. = slight bleeding with frequent suctioning required
4. = moderate bleeding with frequent suctioning required and surgical field visibility is compromised when suctioning is removed
5. = severe bleeding (worst) with constant suctioning required and compromised view
Measured: Duration of operation
Intra-operative Surgical Visibility - Wormald Scale
Standardized scoring systems used by surgeons to rate surgical field quality in FESS:
Wormald scale (0-10):
0 = No bleeding (optimal)
1. = 1-2 points of blood ooze
2. = 3-4 points of ooze
3. = 5-6 points of ooze
4. = 7-8 points of ooze
5. = 9-10 points of ooze
6. = >10 points of ooze, obscuring field
7. = Mild field bleeding with slow post-nasal accumulation
8. = Moderate field bleeding with moderate post-nasal accumulation
9. = Moderate-severe field bleeding with rapid post-nasal accumulation
10. = Severe bleeding (worst) with nose filling rapidly
Measured: Duration of operation up to 3 hours

Secondary outcomes (3)

Rate of Blood Loss
milliliters per minute
Measured: Duration of operation up to 3 hours
Average Mean Arterial Blood Pressure
units of mmHg, measured throughout operation
Measured: Duration of operation up 3 hours/completion of operation
Average Heart Rate
units of beats per minute, measured throughout the operation
Measured: Duration of operation up to 3 hours/completion of surgery

Timeline

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

1 Mar 201730 Mar 2018

First posted7 Sep 2018
Study start1 Mar 2017
Primary completion30 Mar 2018
Study completion30 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic SinusitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03661346
Sponsor's protocol ID: 15-0309
Status last verified: Mar 2017
First submitted: 30 Aug 2018
Last updated: 8 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
Sinus Disease
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps

All Chronic Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Loss and Visibility With Esmolol vs. Labetalol in Endoscopic Sinus Surgery: A Randomized Trial
ClinicalTrials.gov ID: NCT03661346
Acronym / sponsor ID: 15-0309
Conditions: Chronic Sinusitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: The University of Texas Medical Branch, GalvestonUniversity, hospital or other
Study start: 1 Mar 2017 (actual)
Primary completion: 30 Mar 2018 (actual)
Study completion: 30 Mar 2018 (actual)
First posted: 7 Sep 2018 (actual)
Results: Posted 8 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Esmolol	Experimental	Drug: EsmololPatients receiving esmolol when intra-operative MAP > 80 mmHg.
Labetalol	Active comparator	Drug: LabetalolPatients receiving labetalol when intra-operative MAP > 80 mmHg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

History of CRS with or without nasal polyps
Undergoing FESS for CRS
American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease).

Key exclusion criteria (10 listed)

Pregnancy
Asthma
COPD
Bradycardia
Heart failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LabetalolAliquots of 20mg of Labetol • Maximum Dose - 300mg total for case	Drug	Labetalol
EsmololInfusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min	Drug	Esmolol

Primary outcome

Intra-operative Surgical Visibility - Boezaart Scale
Time frame: Duration of operation
Standardized scoring systems used by surgeons to rate surgical field quality in FESS: Boezaart scale (0-5): 0 = no bleeding (optimal) 1. = slight bleeding with no suction required 2. = slight bleeding with occasional suctioning required 3. = slight bleeding with frequent suctioning required 4. = moderate bleeding with frequent suctioning required and surgical field visibility is compromised when suctioning is removed 5. = severe bleeding (worst) with constant suctioning required and compromised view
Intra-operative Surgical Visibility - Wormald Scale
Time frame: Duration of operation up to 3 hours
Standardized scoring systems used by surgeons to rate surgical field quality in FESS: Wormald scale (0-10): 0 = No bleeding (optimal) 1. = 1-2 points of blood ooze 2. = 3-4 points of ooze 3. = 5-6 points of ooze 4. = 7-8 points of ooze 5. = 9-10 points of ooze 6. = >10 points of ooze, obscuring field 7. = Mild field bleeding with slow post-nasal accumulation 8. = Moderate field bleeding with moderate post-nasal accumulation 9. = Moderate-severe field bleeding with rapid post-nasal accumulation 10. = Severe bleeding (worst) with nose filling rapidly

3 secondary outcomes

Rate of Blood Loss
Time frame: Duration of operation up to 3 hours
Average Mean Arterial Blood Pressure
Time frame: Duration of operation up 3 hours/completion of operation
Average Heart Rate
Time frame: Duration of operation up to 3 hours/completion of surgery

Results and safety

Results posted to the registry on 8 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esmolol	13	13
Labetalol	15	15

Primary outcome: Intra-operative Surgical Visibility - Boezaart Scale

Time frame: Duration of operation. Mean (Standard Deviation). Unit: score on a scale

Measure	Esmolol n = 13	Labetalol n = 15
Value	3.1 (.69)	3.1 (.89)

Population analysed: Those analyzed had complete data

Primary outcome: Intra-operative Surgical Visibility - Wormald Scale

Time frame: Duration of operation up to 3 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Esmolol n = 13	Labetalol n = 15
Value	6.1 (1.7)	5.9 (1.9)

Population analysed: Those included had complete data

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected following surgery in recovery room. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esmolol	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Labetalol	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Chronic Sinusitis

Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
Sinus Disease
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamad Chaaban, MD principal investigator

University of Texas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Labetalol and Esmolol in people with Chronic Sinusitis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

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 3 inclusion and 10 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 8 Feb 2021. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intra-operative Surgical Visibility - Boezaart Scale (time frame: Duration of operation). The study lists 2 primary outcomes in all. 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 NCT03661346.

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 8 Feb 2021.