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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03580590
Other study ID # Oral diltiazem in FESS
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date September 1, 2018
Est. completion date January 1, 2020

Study information

Verified date June 2018
Source Assiut University
Contact Moutaz Ismail, MD
Phone 01061844619
Email dr.moetaz89@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

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Study Design


Intervention

Drug:
oral Diltiazem
Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure
IV Tranexamic Acid
Tranexamic acid inhibits fibrinolysis, which reduces blood loss
Placebo Oral Tablet
Placebo Oral Tablet

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

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

Outcome

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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