Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 79 of 299 for:    PROPRANOLOL

Efficacy of Ivabradine Versus Propranolol Premedication During Hypotensive Anesthesia in Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208594
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yasser Mohamed Mohamed Osman, Alexandria University

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.


Condition or disease Intervention/treatment Phase
Ivabradine Propranolol Hypotensive Anesthesia Drug: Ivabradine Drug: Propranolol Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Ivabradine Versus Propranolol Premedication During Hypotensive Anesthesia in Endoscopic Sinus Surgery
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Propranolol
comparing between both drugs for the effect of hypotensive anesthesia

Experimental: 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.
Drug: Ivabradine
comparing between both drugs for the effect of hypotensive anesthesia




Primary Outcome Measures :
  1. Hemodynamic changes : [ Time Frame: Baseline before induction of anesthesia. - Every 30 min throughout deliberate hypotension till termination of NTG infusion. - 5 minutes after the end of deliberate hypote ]

    Mean arterial blood pressure (MABP) in mmHg by invasive monitoring using GE monitor .

    • Heart rate: (beats / minute


  2. amount of Blood loss [ Time Frame: the procedure time ]
    Intraoperative bleeding


Secondary Outcome Measures :
  1. incidence of Complications [ Time Frame: the procedure time ]
    Complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208594


Locations
Layout table for location information
Egypt
Alexandria university Recruiting
Alexandria, Egypt
Contact: yasser mh osman, prof    01006357996 ext 02    yasseralx@hotmail.com   
Principal Investigator: Yasser mh Osman, professor         
Sub-Investigator: Ayman kalefa, lecturer         
Sponsors and Collaborators
Alexandria University

Layout table for additonal information
Responsible Party: Yasser Mohamed Mohamed Osman, assistant professor of anesthesia Alexandria university, Alexandria University
ClinicalTrials.gov Identifier: NCT04208594    
Other Study ID Numbers: 123
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Propranolol
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Antihypertensive Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Vasodilator Agents