Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
Primary Purpose
Hypotension on Induction
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
oral Diltiazem
IV Tranexamic Acid
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension on Induction
Eligibility Criteria
Inclusion Criteria:
include patients who undergoing elective FESS under general anesthesia and meet these criteria:
- Age from 18 - 60 years old. - ASA grade I - II.
Exclusion Criteria:
- - 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1st group
2nd group
3rd group
Arm Description
20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative
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
20 patients will receive oral placebo tablet 3 hours pre-operative
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Incidence of hypotension
systolic blood pressure values are 80-90mmHg Mean arterial pressure is reduced to 50-65mmHg
total consumption of propofol
The investigators will measure the consumption of propofol intraoperatively
Heart Rate
heart beats for minutes
End Tidal CO2
The concentration of carbon dioxide (CO2) in the respiratory gases
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03580590
Brief Title
Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
Official Title
Efficacy of Oral Diltiazem Versus Combination of Oral Diltiazem With Intravenous Tranexamic Acid on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension on Induction
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1st group
Arm Type
Experimental
Arm Description
20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative
Arm Title
2nd group
Arm Type
Experimental
Arm Description
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
Arm Title
3rd group
Arm Type
Placebo Comparator
Arm Description
20 patients will receive oral placebo tablet 3 hours pre-operative
Intervention Type
Drug
Intervention Name(s)
oral Diltiazem
Other Intervention Name(s)
diltiazem
Intervention Description
Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure
Intervention Type
Drug
Intervention Name(s)
IV Tranexamic Acid
Other Intervention Name(s)
capron
Intervention Description
Tranexamic acid inhibits fibrinolysis, which reduces blood loss
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Estimated Blood Loss
Description
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.
Time Frame
end of operation assessment
Secondary Outcome Measure Information:
Title
The Boezaart and van der Merwe intraoperative surgical field scale
Description
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).
Time Frame
Every 15 minutes for the duration of surgery
Title
Incidence of hypotension
Description
systolic blood pressure values are 80-90mmHg Mean arterial pressure is reduced to 50-65mmHg
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
Title
total consumption of propofol
Description
The investigators will measure the consumption of propofol intraoperatively
Time Frame
end of operation assessment
Title
Heart Rate
Description
heart beats for minutes
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
Title
End Tidal CO2
Description
The concentration of carbon dioxide (CO2) in the respiratory gases
Time Frame
End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till the end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
include patients who undergoing elective FESS under general anesthesia and meet these criteria:
- Age from 18 - 60 years old. - ASA grade I - II.
Exclusion Criteria:
- 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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moutaz Ismail, MD
Phone
01061844619
Ext
+2
Email
dr.moetaz89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amany Hassan Abd ElWahab, PhD
Phone
01004610623
Ext
+2
Email
amanihassan1976@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamdy Abbas Youssef, PhD
Organizational Affiliation
Assiut Univerity
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
27687369
Citation
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.
Results Reference
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Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
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