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Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

NCT03580590 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-09

No results posted yet for this study

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.

Conditions

  • Hypotension on Induction

Interventions

DRUG

oral Diltiazem

Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure

DRUG

IV Tranexamic Acid

Tranexamic acid inhibits fibrinolysis, which reduces blood loss

DRUG

Placebo Oral Tablet

Placebo Oral Tablet

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Hamdy Abbas Youssef, PhD · Assiut Univerity

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-11-01
Completion
2020-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03580590 on ClinicalTrials.gov