NCT04208594

Brief Summary

50 Patients, aged from 18 to 39 years, ASA physical status I and II, undergoing endoscopic sinus surgery will be enrolled in the study.The patients will be randomly allocated by simple randomization using a computer programme into two groups by closed envelope technique (having 25 patients in each group): GROUP (P): will receive oral propranolol (INDERAL® -propranolol hydrochloride Ph. Eur. 10mg manufactured by AstraZeneca Egypt under license of AstraZeneca UK), 10 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 10 mg tablet one hour before the induction of anesthesia. GROUP (I): will receive oral ivabradine (Procoralan® 5mg manufactured by Servier laboratories, France), 5 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 5 mg tablet one hour before the induction of anesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 11, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

December 18, 2019

Last Update Submit

December 19, 2019

Conditions

IvabradinePropranololHypotensive Anesthesia

Outcome Measures

Primary Outcomes (2)

  • Hemodynamic changes :

    Mean arterial blood pressure (MABP) in mmHg by invasive monitoring using GE monitor . • Heart rate: (beats / minute

    Baseline before induction of anesthesia. - Every 30 min throughout deliberate hypotension till termination of NTG infusion. - 5 minutes after the end of deliberate hypote

  • amount of Blood loss

    Intraoperative bleeding

    the procedure time

Secondary Outcomes (1)

  • incidence of Complications

    the procedure time

Study Arms (2)

GROUP (P):

ACTIVE COMPARATOR

will receive oral propranolol (INDERAL® -propranolol hydrochloride Ph. Eur. 10mg manufactured by AstraZeneca Egypt under license of AstraZeneca UK), 10 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 10 mg tablet one hour before the induction of anesthesia.

Drug: Propranolol

GROUP (I):

EXPERIMENTAL

will receive oral ivabradine (Procoralan® 5mg manufactured by Servier laboratories, France), 5 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 5 mg tablet one hour before the induction of anesthesia.

Drug: Ivabradine

Interventions

IvabradineDRUG

comparing between both drugs for the effect of hypotensive anesthesia

GROUP (I):
PropranololDRUG

comparing between both drugs for the effect of hypotensive anesthesia

GROUP (P):

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I and II, undergoing endoscopic sinus surgery

You may not qualify if:

  • Patients with cardiovascular disease (hypertension, congestive heart failure, and coronary artery disease).
  • Patients on beta-blockers.
  • Patients with the base line heart rate\<60 beats per minute.
  • Patients with diabetes mellitus (DM).
  • Cerebrovascular insufficiency.
  • Coagulation defects.
  • History of renal or hepatic insufficiency.
  • Hypersensitivity to the study drugs.
  • Patients with history of bronchial asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

IvabradinePropranolol

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia Alexandria university

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 23, 2019

Study Start

December 11, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations

EG(1)