Adrenaline Solution Irrigation and Bleeding During Sinus Surgery

September 15, 2020 updated by: Jordan University of Science and Technology

The Effect of Intranasal Irrigation With Adrenaline Solution on Intraoperative Visualization and Bleeding During Functional Endoscopic Sinus Surgery

Intranasal irrigation with normal saline is routinely used in sinus surgery to clean the tip of the nasal endoscope and clear the surgical field from blood. The purpose of this study is to evaluate the difference in the surgical visualization, surgeon satisfaction and total blood loss when intraoperative irrigation was performed with a solution of normal saline with adrenaline as compared to irrigation with normal saline alone in FESS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Functional Endoscopic Sinus Surgery (FESS) is a common, effective and minimally invasive surgical procedure indicated mainly to treat medically resistant chronic rhinosinusitis with or without nasal polyposis.

The surgery is often performed under general anesthesia and proceeds in anatomically based surgical landmarks steps to facilitate drainage and ventilation of the paranasal sinuses. As any other endoscopic and laparoscopic procedures the operation requires dry surgical field to ensure accurate identification and visualization of structures and smooth surgical dissection progression. Intranasal bleeding during FESS will increase time of surgery and perioperative complications. Also it could affect healing process, increase adhesion formation and lengthening recovery period .

Different methods and maneuvers have been described in the literature to reduce intra-operative bleeding during sinus surgery. These include: elevation of the patient's head, the use of bipolar cautery and powered instruments; premedication with beta blockers; a controlled hypotensive anesthesia technique; total intravenous anesthesia, topical hemostatic biomaterials and local application of vasoconstrictors.

Adrenaline is one of the most commonly used topical vasoconstrective agent. Because systemic absorption of infiltrated adrenaline can give rise to a sudden increase in blood levels of catecholamine compared to topical instillation and thus various life-threatening complications, such as : cardiac arrhythmia, cardiac arrest, cardiomyopathy, pulmonary edema, and central retinal artery occlusion; many surgeons prefer to use instillation of adrenaline over infiltration in FESS

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with American Society of Anesthesiologist (ASA) classification <2
  • Patients with chronic with or without nasal polyposis refractory to medical treatment

Exclusion Criteria:

  • Patients with a history of of bleeding diathesis
  • Patients with severe ischemic heart disease , pulmonary and renal disease
  • Patients with tumours or vascular anomalies
  • Patients with cystic fibrosis, allergic fungal sinusitis and granulomatous disorders
  • Patients who are unable to speak, read and write English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adrenaline saline irrigation
Adrenaline saline irrigation will be prepared by adding one ampule of 0.1 percent adrenaline in one liter bag of normal saline, which made the adrenaline concentration in the solution 1:100 000
Drug: Adrenaline saline irrigation
The surgical field is flushed with 20 cc of Adrenaline saline irrigation. This is in contrast to the standard of care, normal saline irrigation.
Other Names:
  • Epinephrine saline irrigation
NO_INTERVENTION: Normal saline irrigation
Normal saline bag will be used for irrigation during the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Boezaart intraoperative surgical field scale
Time Frame: 2 hours
The Boezaart intra-operative surgical field scale will be used to grade the level of bleeding during surgery. This 0 to 5-point scale will be used to outline the amount of suction required to rid the area of blood disrupting vision. A score of 0 is given for an area with no bleeding, 1 for slight bleeding with no suction required, 2 for slight bleeding requiring suction, 3 for moderate bleeding which improves for several seconds once suction has occurred, 4 for moderate bleeding which restarts directly after suctioning and 5 for severe bleeding which occurs faster then can be removed
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of total blood loss
Time Frame: The volume of blood loss will be measured every 30 minutes from the start of surgery for the duration of 2 hours
Total blood loss will be calculated and measured over the duration of surgery.
The volume of blood loss will be measured every 30 minutes from the start of surgery for the duration of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Investigators

  • Study Chair: Mohannad A Al-Qudah, MD,FACS, Jordan University of Science & Technology & King Abdullah University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

August 11, 2020

Study Completion (ACTUAL)

August 11, 2020

Study Registration Dates

First Submitted

August 23, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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