Endoscopic Sinus SurgeryEarly Phase 1NCT04356196
Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.
A Early Phase 1 study testing Verapamil and Bisoprolol in people with Endoscopic Sinus Surgery and Heart Rate, run by Assiut University at 1 site in Egypt.
Trial summary
The study aims to compare the effect of addition of verapamil and Bisoprolol to general anasthesia aimed reduction in heart rate and blood loss during endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Sinus Surgery, Heart Rate, Blood Loss
- What is being tested?
- Verapamil and Bisoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2021to 30 Dec 2021
- Phase
- Early 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 - 60 years.
- patients of both genders.
- ASA grade I - II.
Who cannot join
- Patient refusal.
- Any contraindication of B- blocker:
- Athma , COPD
- Bradycardia , Heart block
- Acute decompensated heart failure
- Peripheral vascular disease
Show all 13Show fewer
- Any contraindication of calcium channel blocker:
- AV conduction defects (2nd and 3rd degree AV block).
- Sick sinus syndrome .
- Wolf-Parkinson-White Syndrome.
- History of congestive heart failure.
- Patients on long-term ß-blocker therapy.
- Patients with allergy to medication included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to compare the effect of addition of verapamil and Bisoprolol to general anasthesia aimed reduction in heart rate and blood loss during endoscopic sinus surgery.
Read the detailed description
Intra-operative bleeding presents a larger obstacle to endoscopic visualization. Blood obscures the anatomy of the surgical field and dirties the endoscope lens causing greater difficulty with visualization. This situation increases the risk of complications, including brain injury, orbital or optic nerve injury, and catastrophic bleeding from major vessels (e.g., internal carotid artery) 1.
Endoscopic sinus surgery (ESS) is a minimally invasive technique used to restore sinus ventilation and function in patients with recurrent acute or chronic infective sinusitis in whom medical therapy has failed. The term ESS is used to draw attention to the potential for reestablishing natural mucociliary clearance mechanism, drainage and aeration of sinuses, whilst maintaining as much of the normal anatomy as possible. Over last few years this technique has become popular worldwide due to its minimally invasive nature and preservation of mucosa2.
Continued bleeding into the surgical field during ESS not only impairs endoscopic vision but can lead to complications3. Compared with conventional anesthesia, total intravenous anesthesia (TIVA) has been previously reported to result in reduced blood loss when used for FESS. However, few recent studies point out that TIVA may not significantly reduce blood loss 4-5.
Controlled hypotension has been used to reduce bleeding and the need for blood transfusions, and provide a satisfactory bloodless surgical field . Controlled hypotension is defined as a reduction of the systolic blood pressure to 80-90 mm Hg, a reduction of mean arterial pressure (MAP) to 50-65 mm Hg or a 30% reduction of baseline MAP 6. The physiological principle which underlies hypotensive anesthesia is a natural survival mechanism. When profuse bleeding occurs, the blood pressure drops. This drop leads to a reduction or cessation of the bleeding, blood pressure stabilization, and recovery. Accordingly, reducing the patient's blood pressure during surgery can potentially reduce
overall bleeding. Since bleeding in the surgical field is also reduced, the surgical field operating conditions are improved 7 .
Pharmacological agents used for controlled hypotension include those agents that can be used successfully alone and those that are used adjunctively to limit dosage requirements and, therefore, the adverse effects of the other agents. Agents used successfully alone include inhalation anaesthetics, sodium nitroprusside, nitroglycerin, trimethaphan camsilate, alprostadil (prostaglandin E1), adenosine, remifentanil, and agents used in spinal anaesthesia. Agents that can be used alone or in combination include calcium channel antagonists (e.g. nicardipine), beta-adrenoceptor antagonists (beta- blockers) [e.g. bisoprolo, propranolol, esmolol] and fenoldopam. Agents that are mainly used adjunctively include ACE inhibitors and clonidine. New agents and techniques have been recently evaluated for their ability to induce effective hypotension without impairing the perfusion of vital organs 8.
Calcium channel blockers are drugs that block the entry of calcium into the muscle cells of the heart and arteries. Thus, by blocking the entry of calcium, calcium channel blockers reduce electrical conduction within the heart, decrease the force of contraction (work) of the muscle cells, and dilate arteries which reduces blood pressure and thereby the effort the heart must exert to pump blood 9.
Although calcium channel blockers have a similar mechanism of action, they differ in their ability to affect heart muscle vs. arteries, and they differ in their ability to affect heart rate and contraction. For example; verapamil (Covera-HS, Verelan PM, Calan), reduces the strength and rate of the heart's contraction and are used in treating abnormal heart rhythms10.
Beta-blockers antagonise the effects of sympathetic nerve stimulation or circulating catecholamines at beta-adrenoceptors which are widely distributed throughout body systems. Beta1-receptors are predominant in the heart (and kidney) while beta2- receptors are predominant in other organs such as the lung, peripheral blood vessels and skeletal muscle11.
- Conditions
- Endoscopic Sinus Surgery, Heart Rate, Blood Loss
- Being tested
- Verapamil, Bisoprolol, Placebo oral tablet
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Also called Isoptin
Verapamil is a phenylalkylamine calcium channel blocker used in the treatment of high blood pressure, heart arrhythmias, and angina
BisoprololDrug
Also called concor
Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure.
Placebo oral tabletDrug
Placebo oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Verapamil group | Experimental | 45 patients will receive 80 mg oral verapamil 3 hours pre-operative Receives: Drug: Verapamil |
| Bisoprolol group | Experimental | 45 patients will receive Bisoprolol 5mg PO 3 hours preoperative Receives: Drug: Bisoprolol |
| placebo group | Experimental | 45 patients will receive placebo tablet PO 3 hours preoperative . Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
heart beats for minutes
Measured: intraoperative
Estimated Blood Loss
Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery dividing by surgical time in hours.
Measured: end of operation assessment
Secondary outcomes (3)
The Boezaart and van der Merwe intraoperative surgical field scale
Boezaart Bleeding Scale (BBS) (0 - no bleeding (cadaveric conditions), 1 - Slight bleeding, no suctioning required, 2 - Slight bleeding, occasional suctioning required, 3 - Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed, 4 - Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed, 5 - Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).
Measured: Every 15 minutes for the duration of surgery
plasma norepinephrine concentrations
plasma norepinephrine concentrations measured by enzyme immunoassay as venous blood samples about 4ml will be collected from each patient under aseptic condition
Measured: baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.
serum cortisol concentrations
serum cortisol will be measured by enzyme immunoassay as venous blood samples about 4ml will be collected from each patient under aseptic condition
Measured: baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start15 Jun 2021
- Primary completion28 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Hassan Refaat AL-Quossi, Assiut University
- Investigators
- Mohammed Sayed Hassanein, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356196
- Sponsor's protocol ID
- Verapamil, Bisoprolol in ESS
- Status last verified
- Nov 2021
- First submitted
- 18 Apr 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.
PubMed 23844295Hadad G, Bassagasteguy L, Carrau RL, Mataza JC, Kassam A, Snyderman CH, Mintz A. A novel reconstructive technique after endoscopic expanded endonasal approaches: vascular pedicle nasoseptal flap. Laryngoscope. 2006 Oct;116(10):1882-6. doi: 10.1097/01.mlg.0000234933.37779.e4.
PubMed 17003708Stammberger H. Endoscopic endonasal surgery--concepts in treatment of recurring rhinosinusitis. Part II. Surgical technique. Otolaryngol Head Neck Surg. 1986 Feb;94(2):147-56. doi: 10.1177/019459988609400203.
PubMed 3083327Stankiewicz JA, Lal D, Connor M, Welch K. Complications in endoscopic sinus surgery for chronic rhinosinusitis: a 25-year experience. Laryngoscope. 2011 Dec;121(12):2684-701. doi: 10.1002/lary.21446. Epub 2011 Nov 15.
PubMed 22086769Eberhart LH, Folz BJ, Wulf H, Geldner G. Intravenous anesthesia provides optimal surgical conditions during microscopic and endoscopic sinus surgery. Laryngoscope. 2003 Aug;113(8):1369-73. doi: 10.1097/00005537-200308000-00019.
PubMed 12897561Ankichetty SP, Ponniah M, Cherian V, Thomas S, Kumar K, Jeslin L, Jeyasheela K, Malhotra N. Comparison of total intravenous anesthesia using propofol and inhalational anesthesia using isoflurane for controlled hypotension in functional endoscopic sinus surgery. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):328-32. doi: 10.4103/0970-9185.83675.
PubMed 21897501Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
PubMed 11212044Tobias JD. Controlled hypotension in children: a critical review of available agents. Paediatr Drugs. 2002;4(7):439-53. doi: 10.2165/00128072-200204070-00003.
PubMed 12083972Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007.
PubMed 17488147
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.
- ClinicalTrials.gov ID
- NCT04356196
- Acronym / sponsor ID
- Verapamil, Bisoprolol in ESS
- Conditions
- Endoscopic Sinus Surgery, Heart Rate, Blood Loss
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 28 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 22 Apr 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.
The study aims to compare the effect of addition of verapamil and Bisoprolol to general anasthesia aimed reduction in heart rate and blood loss during endoscopic sinus surgery.
Detailed description
Intra-operative bleeding presents a larger obstacle to endoscopic visualization. Blood obscures the anatomy of the surgical field and dirties the endoscope lens causing greater difficulty with visualization. This situation increases the risk of complications, including brain injury, orbital or optic nerve injury, and catastrophic bleeding from major vessels (e.g., internal carotid artery) 1.
Endoscopic sinus surgery (ESS) is a minimally invasive technique used to restore sinus ventilation and function in patients with recurrent acute or chronic infective sinusitis in whom medical therapy has failed. The term ESS is used to draw attention to the potential for reestablishing natural mucociliary clearance mechanism, drainage and aeration of sinuses, whilst maintaining as much of the normal anatomy as possible. Over last few years this technique has become popular worldwide due to its minimally invasive nature and preservation of mucosa2.
Continued bleeding into the surgical field during ESS not only impairs endoscopic vision but can lead to complications3. Compared with conventional anesthesia, total intravenous anesthesia (TIVA) has been previously reported to result in reduced blood loss when used for FESS. However, few recent studies point out that TIVA may not significantly reduce blood loss 4-5.
Controlled hypotension has been used to reduce bleeding and the need for blood transfusions, and provide a satisfactory bloodless surgical field . Controlled hypotension is defined as a reduction of the systolic blood pressure to 80-90 mm Hg, a reduction of mean arterial pressure (MAP) to 50-65 mm Hg or a 30% reduction of baseline MAP 6. The physiological principle which underlies hypotensive anesthesia is a natural survival mechanism. When profuse bleeding occurs, the blood pressure drops. This drop leads to a reduction or cessation of the bleeding, blood pressure stabilization, and recovery. Accordingly, reducing the patient's blood pressure during surgery can potentially reduce
overall bleeding. Since bleeding in the surgical field is also reduced, the surgical field operating conditions are improved 7 .
Pharmacological agents used for controlled hypotension include those agents that can be used successfully alone and those that are used adjunctively to limit dosage requirements and, therefore, the adverse effects of the other agents. Agents used successfully alone include inhalation anaesthetics, sodium nitroprusside, nitroglycerin, trimethaphan camsilate, alprostadil (prostaglandin E1), adenosine, remifentanil, and agents used in spinal anaesthesia. Agents that can be used alone or in combination include calcium channel antagonists (e.g. nicardipine), beta-adrenoceptor antagonists (beta- blockers) [e.g. bisoprolo, propranolol, esmolol] and fenoldopam. Agents that are mainly used adjunctively include ACE inhibitors and clonidine. New agents and techniques have been recently evaluated for their ability to induce effective hypotension without impairing the perfusion of vital organs 8.
Calcium channel blockers are drugs that block the entry of calcium into the muscle cells of the heart and arteries. Thus, by blocking the entry of calcium, calcium channel blockers reduce electrical conduction within the heart, decrease the force of contraction (work) of the muscle cells, and dilate arteries which reduces blood pressure and thereby the effort the heart must exert to pump blood 9.
Although calcium channel blockers have a similar mechanism of action, they differ in their ability to affect heart muscle vs. arteries, and they differ in their ability to affect heart rate and contraction. For example; verapamil (Covera-HS, Verelan PM, Calan), reduces the strength and rate of the heart's contraction and are used in treating abnormal heart rhythms10.
Beta-blockers antagonise the effects of sympathetic nerve stimulation or circulating catecholamines at beta-adrenoceptors which are widely distributed throughout body systems. Beta1-receptors are predominant in the heart (and kidney) while beta2- receptors are predominant in other organs such as the lung, peripheral blood vessels and skeletal muscle11.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verapamil group | Experimental | Drug: Verapamil45 patients will receive 80 mg oral verapamil 3 hours pre-operative |
| Bisoprolol group | Experimental | Drug: Bisoprolol45 patients will receive Bisoprolol 5mg PO 3 hours preoperative |
| placebo group | Experimental | Drug: Placebo oral tablet45 patients will receive placebo tablet PO 3 hours preoperative . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18 - 60 years.
- patients of both genders.
- ASA grade I - II.
Key exclusion criteria (13 listed)
- Patient refusal.
- Any contraindication of B- blocker:
- Any contraindication of calcium channel blocker:
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 |
|---|---|---|
| VerapamilAlso: IsoptinVerapamil is a phenylalkylamine calcium channel blocker used in the treatment of high blood pressure, heart arrhythmias, and angina | Drug | Verapamil group |
| BisoprololAlso: concorBisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure. | Drug | Bisoprolol group |
| Placebo oral tabletPlacebo oral tablet | Drug | placebo group |
Primary outcome
Heart Rate
Time frame: intraoperative
heart beats for minutes
Estimated Blood Loss
Time frame: end of operation assessment
Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery dividing by surgical time in hours.
3 secondary outcomes
The Boezaart and van der Merwe intraoperative surgical field scale
Time frame: Every 15 minutes for the duration of surgery
plasma norepinephrine concentrations
Time frame: baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.
serum cortisol concentrations
Time frame: baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Background: PubMed 23844295Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.
- Background: PubMed 17003708Hadad G, Bassagasteguy L, Carrau RL, Mataza JC, Kassam A, Snyderman CH, Mintz A. A novel reconstructive technique after endoscopic expanded endonasal approaches: vascular pedicle nasoseptal flap. Laryngoscope. 2006 Oct;116(10):1882-6. doi: 10.1097/01.mlg.0000234933.37779.e4.
- Background: PubMed 3083327Stammberger H. Endoscopic endonasal surgery--concepts in treatment of recurring rhinosinusitis. Part II. Surgical technique. Otolaryngol Head Neck Surg. 1986 Feb;94(2):147-56. doi: 10.1177/019459988609400203.
- Background: PubMed 22086769Stankiewicz JA, Lal D, Connor M, Welch K. Complications in endoscopic sinus surgery for chronic rhinosinusitis: a 25-year experience. Laryngoscope. 2011 Dec;121(12):2684-701. doi: 10.1002/lary.21446. Epub 2011 Nov 15.
- Background: PubMed 12897561Eberhart LH, Folz BJ, Wulf H, Geldner G. Intravenous anesthesia provides optimal surgical conditions during microscopic and endoscopic sinus surgery. Laryngoscope. 2003 Aug;113(8):1369-73. doi: 10.1097/00005537-200308000-00019.
- Background: PubMed 21897501Ankichetty SP, Ponniah M, Cherian V, Thomas S, Kumar K, Jeslin L, Jeyasheela K, Malhotra N. Comparison of total intravenous anesthesia using propofol and inhalational anesthesia using isoflurane for controlled hypotension in functional endoscopic sinus surgery. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):328-32. doi: 10.4103/0970-9185.83675.
- Background: PubMed 11212044Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
- Background: PubMed 12083972Tobias JD. Controlled hypotension in children: a critical review of available agents. Paediatr Drugs. 2002;4(7):439-53. doi: 10.2165/00128072-200204070-00003.
- Background: PubMed 17488147Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007.
Related trials for Endoscopic Sinus Surgery
Recruiting
Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
Fospropofol Disodium
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
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.
Mohammed Sayed Hassanein principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Verapamil and Bisoprolol in people with Endoscopic Sinus Surgery and Heart Rate, run by Assiut 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Dec 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Heart Rate (time frame: intraoperative). 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 NCT04356196, which also lists 9 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 3 Dec 2021.