Hypotension on Induction Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | January 1, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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: 1. AV conduction defects (2nd and 3rd degree AV block). 2. Sick sinus syndrome. 3. Wolf-Parkinson-White Syndrome. 4. History of congestive heart failure. 5. Patients on long-term ß-blocker therapy. - Patients with allergy to medication included in the study. - Any contraindication of Tranexamic Acid: 1. bleeding disorders. 2. pregnant or breastfeeding mothers. 3. patient under the influence of anticoagulants. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | end of operation assessment | |
Secondary | 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). | Every 15 minutes for the duration of surgery | |
Secondary | Incidence of hypotension | systolic blood pressure values are 80-90mmHg Mean arterial pressure is reduced to 50-65mmHg | 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 | |
Secondary | total consumption of propofol | The investigators will measure the consumption of propofol intraoperatively | end of operation assessment | |
Secondary | Heart Rate | heart beats for minutes | Heart Rate recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes postoperative | |
Secondary | End Tidal CO2 | The concentration of carbon dioxide (CO2) in the respiratory gases | End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till the end of surgery |
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