Hypotension on InductionEarly Phase 1NCT03580590
Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
A Early Phase 1 study testing oral Diltiazem and IV Tranexamic Acid in people with Hypotension on Induction, run by Assiut University.
Trial summary
The primary endpoint is the effect of the addition of oral Diltiazem and Tranexamic Acid to general anesthesia aided reduction in blood loss during functional endoscopic sinus surgery (FESS). The secondary endpoint is surgeon's assessment of the surgical field and hemodynamics. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- oral Diltiazem and IV Tranexamic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Jan 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- include patients who undergoing elective FESS under general anesthesia and meet these criteria:
- Age from 18 - 60 years old. - ASA grade I - II.
Who cannot join
- - Patient refusal.
- 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.
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- Patients on long-term ß-blocker therapy.
- Patients with allergy to medication included in the study.
- Any contraindication of Tranexamic Acid:
- bleeding disorders.
- pregnant or breastfeeding mothers.
- patient under the influence of anticoagulants.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Oral Diltiazem Versus Combination of Oral Diltiazem With Intravenous Tranexamic Acid on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
- The primary endpoint is the effect of the addition of oral Diltiazem and Tranexamic Acid to general anesthesia aided reduction in blood loss during functional endoscopic sinus surgery (FESS).
- The secondary endpoint is surgeon's assessment of the surgical field and hemodynamics.
Read the detailed description
Functional endoscopic sinus surgery (FESS) 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.
Continued bleeding into the surgical field during FESS not only impairs endoscopic vision but can lead to complications.
Controlled hypotension is a technique used to limit intraoperative blood loss to provide the best possible field for surgery. 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 In hypotensive anesthesia, the patient's baseline mean arterial pressure (MAP) is reduced by 30 %. Consequently, the systolic blood pressure values are about 80-90mmHg and the MAP is reduced to 50- 65mmHg.
Hypotensive anesthesia is considered to be a suitable anesthetic technique for those patients who will be undergoing spinal surgery, hip or knee arthroplasty, craniosynostosis, hepatic resections, and major maxillofacial operations. Benefits for controlled hypotension for FESS include the reduction in blood loss with improved quality of the surgical field.
Various agent's anesthetic agents, analgesics, and hypotensive drugs, that have been used for achieving hypotensive anesthesia:
- Volatile Anesthetic Agents. Most anesthetic agents have a hypotensive effect such as isoflurane, sevoflurane, and desflurane, high concentrations are required to achieve a significant reduction in intraoperative bleeding, and these concentrations may lead to hepatic or renal injury.
- Propofol. has a potent hypotensive capability, but normal blood pressure will be rapidly restored when the propofol infusion is discontinued. Although a short-term propofol infusion is safe, a long-term Propofol infusion can cause propofol infusion syndrome in children.
- Alfentanil, Sufentanil, and Remifentanil. potent synthetic and short-acting opioid drugs, Since the recovery times from this type of anesthesia are also short, they are widely used for hypotensive anesthesia. d.Nitrates. SNP and NTG are two very potent hypotensive agents that are commonly used for inducing hypotensive anesthesia. Reflex tachycardia is an unwanted effect which often occurs with nitrates administration and can be prevented by a small dose of the beta-adrenoceptor antagonist, such as esmolol or propranolol premedication. e-beta-Adrenoceptor Antagonists. They effectively used for inducing hypotensive anesthesia when administered either as a single hypotensive agent or in combination with SNP. Nonselective beta-antagonists, such as labetalol, may cause bronchoconstriction and should be avoided in asthmatic patients. The hypotensive action of beta-adrenoceptor antagonists is achieved by reducing cardiac output. So, not suitable for the patient with underlying heart failure. f-Calcium Channel Antagonists. such as nifedipine or nicardipine, are commonly used as hypotensive drugs.
Diltiazem, a calcium channel blocker, blocks the influx of calcium into smooth muscle cells and cardiac muscle cells. This causes relaxation of the muscle, thereby causing reduced arteriolar tone and fall in blood pressure.
Tranexamic acid is a synthetic amino acid that inhibits fibrinolysis, which reduces blood loss and the need for blood transfusion in total knee arthroplasty, spine surgery, and cardiac surgery. It has seen wide application in a variety of surgical procedures since then.
- Conditions
- Hypotension on Induction
- Being tested
- oral Diltiazem, IV Tranexamic Acid, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral DiltiazemDrug
Also called diltiazem
Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure
IV Tranexamic AcidDrug
Also called capron
Tranexamic acid inhibits fibrinolysis, which reduces blood loss
Placebo Oral TabletDrug
Placebo Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| 1st group | Experimental | 20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative Receives: Drug: oral Diltiazem |
| 2nd group | Experimental | 20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative+ 10 mg/kg IV Tranexamic Acid slow infusion with saline half an hour before the induction of anesthesia Receives: Drug: oral Diltiazem; Drug: IV Tranexamic Acid |
| 3rd group | Placebo comparator | 20 patients will receive oral placebo tablet 3 hours pre-operative Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (5)
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
Incidence of hypotension
systolic blood pressure values are 80-90mmHg Mean arterial pressure is reduced to 50-65mmHg
Measured: Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes post operative
total consumption of propofol
The investigators will measure the consumption of propofol intraoperatively
Measured: end of operation assessment
Heart Rate
heart beats for minutes
Measured: Heart Rate recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes postoperative
End Tidal CO2
The concentration of carbon dioxide (CO2) in the respiratory gases
Measured: End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till 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 posted9 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension on InductionStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moutaz Ragab Ismail Ibrahim, Assiut University
- Investigators
- Hamdy Abbas Youssef, PhD, Study director, Assiut Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580590
- Sponsor's protocol ID
- Oral diltiazem in FESS
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aravindan A, Subramanium R, Chhabra A, Datta PK, Rewari V, Sharma SC, Kumar R. Magnesium sulfate or diltiazem as adjuvants to total intravenous anesthesia to reduce blood loss in functional endoscopic sinus surgery. J Clin Anesth. 2016 Nov;34:179-85. doi: 10.1016/j.jclinane.2016.03.068. Epub 2016 May 10.
PubMed 27687369
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Diltiazem Versus Combination of Oral Diltiazem With Intravenous Tranexamic Acid on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT03580590
- Acronym / sponsor ID
- Oral diltiazem in FESS
- Conditions
- Hypotension on Induction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 9 Jul 2018 (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 primary endpoint is the effect of the addition of oral Diltiazem and Tranexamic Acid to general anesthesia aided reduction in blood loss during functional endoscopic sinus surgery (FESS).
- The secondary endpoint is surgeon's assessment of the surgical field and hemodynamics.
Detailed description
Functional endoscopic sinus surgery (FESS) 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.
Continued bleeding into the surgical field during FESS not only impairs endoscopic vision but can lead to complications.
Controlled hypotension is a technique used to limit intraoperative blood loss to provide the best possible field for surgery. 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 In hypotensive anesthesia, the patient's baseline mean arterial pressure (MAP) is reduced by 30 %. Consequently, the systolic blood pressure values are about 80-90mmHg and the MAP is reduced to 50- 65mmHg.
Hypotensive anesthesia is considered to be a suitable anesthetic technique for those patients who will be undergoing spinal surgery, hip or knee arthroplasty, craniosynostosis, hepatic resections, and major maxillofacial operations. Benefits for controlled hypotension for FESS include the reduction in blood loss with improved quality of the surgical field.
Various agent's anesthetic agents, analgesics, and hypotensive drugs, that have been used for achieving hypotensive anesthesia:
- Volatile Anesthetic Agents. Most anesthetic agents have a hypotensive effect such as isoflurane, sevoflurane, and desflurane, high concentrations are required to achieve a significant reduction in intraoperative bleeding, and these concentrations may lead to hepatic or renal injury.
- Propofol. has a potent hypotensive capability, but normal blood pressure will be rapidly restored when the propofol infusion is discontinued. Although a short-term propofol infusion is safe, a long-term Propofol infusion can cause propofol infusion syndrome in children.
- Alfentanil, Sufentanil, and Remifentanil. potent synthetic and short-acting opioid drugs, Since the recovery times from this type of anesthesia are also short, they are widely used for hypotensive anesthesia. d.Nitrates. SNP and NTG are two very potent hypotensive agents that are commonly used for inducing hypotensive anesthesia. Reflex tachycardia is an unwanted effect which often occurs with nitrates administration and can be prevented by a small dose of the beta-adrenoceptor antagonist, such as esmolol or propranolol premedication. e-beta-Adrenoceptor Antagonists. They effectively used for inducing hypotensive anesthesia when administered either as a single hypotensive agent or in combination with SNP. Nonselective beta-antagonists, such as labetalol, may cause bronchoconstriction and should be avoided in asthmatic patients. The hypotensive action of beta-adrenoceptor antagonists is achieved by reducing cardiac output. So, not suitable for the patient with underlying heart failure. f-Calcium Channel Antagonists. such as nifedipine or nicardipine, are commonly used as hypotensive drugs.
Diltiazem, a calcium channel blocker, blocks the influx of calcium into smooth muscle cells and cardiac muscle cells. This causes relaxation of the muscle, thereby causing reduced arteriolar tone and fall in blood pressure.
Tranexamic acid is a synthetic amino acid that inhibits fibrinolysis, which reduces blood loss and the need for blood transfusion in total knee arthroplasty, spine surgery, and cardiac surgery. It has seen wide application in a variety of surgical procedures since then.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st group | Experimental | Drug: oral Diltiazem20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative |
| 2nd group | Experimental | Drug: oral Diltiazem, Drug: IV Tranexamic Acid20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative+ 10 mg/kg IV Tranexamic Acid slow infusion with saline half an hour before the induction of anesthesia |
| 3rd group | Placebo comparator | Drug: Placebo Oral Tablet20 patients will receive oral placebo tablet 3 hours pre-operative |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- include patients who undergoing elective FESS under general anesthesia and meet these criteria:
- Age from 18 - 60 years old. - ASA grade I - II.
Key exclusion criteria (12 listed)
- - Patient refusal.
- Any contraindication of calcium channel blocker:
- Patients with allergy to medication included in the study.
- Any contraindication of Tranexamic Acid:
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 |
|---|---|---|
| oral DiltiazemAlso: diltiazemDiltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure | Drug | 1st group, 2nd group |
| IV Tranexamic AcidAlso: capronTranexamic acid inhibits fibrinolysis, which reduces blood loss | Drug | 2nd group |
| Placebo Oral TabletPlacebo Oral Tablet | Drug | 3rd group |
Primary outcome
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.
5 secondary outcomes
The Boezaart and van der Merwe intraoperative surgical field scale
Time frame: Every 15 minutes for the duration of surgery
Incidence of hypotension
Time frame: Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes post operative
total consumption of propofol
Time frame: end of operation assessment
Heart Rate
Time frame: Heart Rate recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes postoperative
End Tidal CO2
Time frame: End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till 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 9 Jul 2018.
- Background: PubMed 27687369Aravindan A, Subramanium R, Chhabra A, Datta PK, Rewari V, Sharma SC, Kumar R. Magnesium sulfate or diltiazem as adjuvants to total intravenous anesthesia to reduce blood loss in functional endoscopic sinus surgery. J Clin Anesth. 2016 Nov;34:179-85. doi: 10.1016/j.jclinane.2016.03.068. Epub 2016 May 10.
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Anesthesia
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.
Hamdy Abbas Youssef, PhD study director
Assiut Univerity
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing oral Diltiazem and IV Tranexamic Acid in people with Hypotension on Induction, run by Assiut University.
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 12 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 9 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
Contact Moutaz Ismail, MD (01061844619 ext. +2, dr.moetaz89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Blood Loss (time frame: end of operation assessment). 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 NCT03580590, which also lists 1 linked publication.
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 9 Jul 2018.