Chronic Rhinosinusitis (Diagnosis)Phase 1NCT04551703
Adrenaline Solution Irrigation and Bleeding During Sinus Surgery
A Phase 1 study testing Adrenaline saline irrigation in people with Chronic Rhinosinusitis (Diagnosis), run by Jordan University of Science and Technology.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Adrenaline saline irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 11 Aug 2020
- Phase
- Phase 1
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologist (ASA) classification <2
- Patients with chronic with or without nasal polyposis refractory to medical treatment
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Adrenaline saline irrigation
- Keywords
- Sinusitis, Nasal Polyp, Endoscopic Sinus Surgery, Adrenaline
- Medical subject headings
- Disease, Sinusitis, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenaline saline irrigationDrug
Also called Epinephrine 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.
| Study group | Role | What they receive |
|---|---|---|
| Adrenaline saline irrigation | Experimental | 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 Receives: Drug: Adrenaline saline irrigation |
| Normal saline irrigation | No intervention | Normal saline bag will be used for irrigation during the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Boezaart intraoperative surgical field scale
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
Measured: 2 hours
Secondary outcomes (1)
Volume of total blood loss
Total blood loss will be calculated and measured over the duration of surgery.
Measured: The volume of blood loss will be measured every 30 minutes from the start of surgery for the duration of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Jul 2016
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will randomize into two groups based on computer generating numbers. Group 1 will have the usual method of irrigation with normal saline during surgery whereas group 2 have irrigation with 1:100 000 adrenaline in normal saline. The solution will be prepared by the senior resident through 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. The investigators who collected the data will be blinded to the content of both preparations. Irrigation with either solution will be used during the procedure through a 20 mL syringe attached to an olive tip long curved suction.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohannad A Al-Qudah, MD,FACS, Study chair, Jordan University of Science & Technology & King Abdullah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551703
- Sponsor's protocol ID
- 221
- Status last verified
- Sep 2020
- First submitted
- 23 Aug 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Higgins TS, Hwang PH, Kingdom TT, Orlandi RR, Stammberger H, Han JK. Systematic review of topical vasoconstrictors in endoscopic sinus surgery. Laryngoscope. 2011 Feb;121(2):422-32. doi: 10.1002/lary.21286. Epub 2011 Jan 13.
PubMed 21271600Saif AM, Farboud A, Delfosse E, Pope L, Adke M. Assessing the safety and efficacy of drugs used in preparing the nose for diagnostic and therapeutic procedures: a systematic review. Clin Otolaryngol. 2016 Oct;41(5):546-63. doi: 10.1111/coa.12563. Epub 2016 Feb 11.
PubMed 26452438Yim MT, Ahmed OG, Takashima M. Evaluating real-time effects of topical 1:1000 epinephrine in endoscopic sinus and skull-base surgery on hemodynamic parameters through intraoperative arterial line monitoring. Int Forum Allergy Rhinol. 2017 Nov;7(11):1065-1069. doi: 10.1002/alr.22012. Epub 2017 Sep 18.
PubMed 28922579Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.
PubMed 23255493Gan EC, Alsaleh S, Manji J, Habib AR, Amanian A, Javer AR. Hemostatic effect of hot saline irrigation during functional endoscopic sinus surgery: a randomized controlled trial. Int Forum Allergy Rhinol. 2014 Nov;4(11):877-84. doi: 10.1002/alr.21376. Epub 2014 Aug 18.
PubMed 25137523
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Irrigation With Adrenaline Solution on Intraoperative Visualization and Bleeding During Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT04551703
- Acronym / sponsor ID
- 221
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Sinusitis, Nasal Polyp, Endoscopic Sinus Surgery, Adrenaline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will randomize into two groups based on computer generating numbers. Group 1 will have the usual method of irrigation with normal saline during surgery whereas group 2 have irrigation with 1:100 000 adrenaline in normal saline. The solution will be prepared by the senior resident through 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. The investigators who collected the data will be blinded to the content of both preparations. Irrigation with either solution will be used during the procedure through a 20 mL syringe attached to an olive tip long curved suction.
| Arm | Type | Receives |
|---|---|---|
| Adrenaline saline irrigation | Experimental | Drug: Adrenaline saline irrigationAdrenaline 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 |
| Normal saline irrigation | No intervention | –Normal saline bag will be used for irrigation during the procedure |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with American Society of Anesthesiologist (ASA) classification <2
- Patients with chronic with or without nasal polyposis refractory to medical treatment
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Adrenaline saline irrigationAlso: Epinephrine saline irrigationThe surgical field is flushed with 20 cc of Adrenaline saline irrigation. This is in contrast to the standard of care, normal saline irrigation. | Drug | Adrenaline saline irrigation |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Results publication: PubMed 21271600Higgins TS, Hwang PH, Kingdom TT, Orlandi RR, Stammberger H, Han JK. Systematic review of topical vasoconstrictors in endoscopic sinus surgery. Laryngoscope. 2011 Feb;121(2):422-32. doi: 10.1002/lary.21286. Epub 2011 Jan 13.
- Results publication: PubMed 26452438Saif AM, Farboud A, Delfosse E, Pope L, Adke M. Assessing the safety and efficacy of drugs used in preparing the nose for diagnostic and therapeutic procedures: a systematic review. Clin Otolaryngol. 2016 Oct;41(5):546-63. doi: 10.1111/coa.12563. Epub 2016 Feb 11.
- Results publication: PubMed 28922579Yim MT, Ahmed OG, Takashima M. Evaluating real-time effects of topical 1:1000 epinephrine in endoscopic sinus and skull-base surgery on hemodynamic parameters through intraoperative arterial line monitoring. Int Forum Allergy Rhinol. 2017 Nov;7(11):1065-1069. doi: 10.1002/alr.22012. Epub 2017 Sep 18.
- Results publication: PubMed 23255493Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.
- Results publication: PubMed 25137523Gan EC, Alsaleh S, Manji J, Habib AR, Amanian A, Javer AR. Hemostatic effect of hot saline irrigation during functional endoscopic sinus surgery: a randomized controlled trial. Int Forum Allergy Rhinol. 2014 Nov;4(11):877-84. doi: 10.1002/alr.21376. Epub 2014 Aug 18.
- Individual participant dataSharing planned: No
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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.
Mohannad A Al-Qudah, MD,FACS study chair
Jordan University of Science & Technology & King Abdullah University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adrenaline saline irrigation in people with Chronic Rhinosinusitis (Diagnosis), run by Jordan University of Science and Technology.
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 2 inclusion and 5 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The Boezaart intraoperative surgical field scale (time frame: 2 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 NCT04551703, which also lists 5 linked publications.
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 16 Sep 2020.