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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.
Show all 12Show fewer
  • 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.

Amany Hassan Abd ElWahab, PhD contact

01004610623 ext. +2

amanihassan1976@yahoo.com

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:

  1. 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.
  2. 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.
  3. 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.

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 groups in NCT03580590
Study groupRoleWhat they receive
1st groupExperimental20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative
Receives: Drug: oral Diltiazem
2nd groupExperimental20 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 groupPlacebo comparator20 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.

  1. 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)
  1. 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

  2. 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

  3. total consumption of propofol

    The investigators will measure the consumption of propofol intraoperatively

    Measured: end of operation assessment

  4. 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

  5. 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.

  1. First posted9 Jul 2018
  2. Study start1 Sep 2018 (estimated)
  3. Primary completion1 Nov 2019 (estimated)
  4. Study completion1 Jan 2020 (estimated)

Resources

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)
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

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.

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