NCT03661346

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 8, 2021

Completed
Last Updated

February 8, 2021

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

August 30, 2018

Results QC Date

May 20, 2019

Last Update Submit

January 19, 2021

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Duration of operation up to 3 hours

Secondary Outcomes (3)

  • Rate of Blood Loss

    Duration of operation up to 3 hours

  • Average Mean Arterial Blood Pressure

    Duration of operation up 3 hours/completion of operation

  • Average Heart Rate

    Duration of operation up to 3 hours/completion of surgery

Study Arms (2)

Esmolol

EXPERIMENTAL

Patients receiving esmolol when intra-operative MAP \> 80 mmHg.

Drug: Esmolol

Labetalol

ACTIVE COMPARATOR

Patients receiving labetalol when intra-operative MAP \> 80 mmHg

Drug: Labetalol

Interventions

LabetalolDRUG

Aliquots of 20mg of Labetol • Maximum Dose - 300mg total for case

Labetalol
EsmololDRUG

Infusion - 0.1mg/kg/min • Maximum Dose - after 30 minutes, 0.3mg/kg/min

Esmolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Pregnancy
  • Asthma
  • COPD
  • Bradycardia
  • Heart failure
  • End stage renal disease
  • Cerebrovascular accident
  • Diabetes mellitus
  • Preoperative use of NSAIDs, aspirin, or beta-blockers
  • Body mass index (BMI) greater than 40 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

MeSH Terms

Interventions

Labetalolesmolol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAmines

Results Point of Contact

Title
Dr. Mohamad Chaaban
Organization
University of Texas Medical Branch - Galveston
mrchaaba@UTMB.EDU
281-338-0829

Study Officials

  • Mohamad Chaaban, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 7, 2018

Study Start

March 1, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

February 8, 2021

Results First Posted

February 8, 2021

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
3 months to 3 years at time of publication (if applicable)

Locations

US(1)