NCT03580590

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 9, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

June 12, 2018

Last Update Submit

June 26, 2018

Conditions

Hypotension on Induction

Outcome Measures

Primary Outcomes (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.

    end of operation assessment

Secondary Outcomes (5)

  • The Boezaart and van der Merwe intraoperative surgical field scale

    Every 15 minutes for the duration of surgery

  • Incidence of hypotension

    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

  • total consumption of propofol

    end of operation assessment

  • Heart Rate

    Heart Rate recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes postoperative

  • End Tidal CO2

    End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till the end of surgery

Study Arms (3)

1st group

EXPERIMENTAL

20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative

Drug: oral Diltiazem

2nd group

EXPERIMENTAL

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

Drug: oral DiltiazemDrug: IV Tranexamic Acid

3rd group

PLACEBO COMPARATOR

20 patients will receive oral placebo tablet 3 hours pre-operative

Drug: Placebo Oral Tablet

Interventions

oral DiltiazemDRUG

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

Also known as: diltiazem
1st group2nd group
IV Tranexamic AcidDRUG

Tranexamic acid inhibits fibrinolysis, which reduces blood loss

Also known as: capron
2nd group
Placebo Oral TabletDRUG

Placebo Oral Tablet

3rd group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • include patients who undergoing elective FESS under general anesthesia and meet these criteria:
  • \- Age from 18 - 60 years old. - ASA grade I - II.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 27687369BACKGROUND

MeSH Terms

Interventions

DiltiazemTranexamic Acidcapron

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Hamdy Abbas Youssef, PhD

    Assiut Univerity

    STUDY DIRECTOR

Central Study Contacts

Moutaz Ismail, MD

CONTACT

01061844619dr.moetaz89@gmail.com

Amany Hassan Abd ElWahab, PhD

CONTACT

01004610623amanihassan1976@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 9, 2018

Study Start

September 1, 2018

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

July 9, 2018

Record last verified: 2018-06