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Granisetron in Diabetic Parturients Decrease Spinal Induced Hypotension

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ClinicalTrials.gov Identifier: NCT03091881
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed A Elsadany, MD, Suez Canal University

Brief Summary:
Diabetic Parturients are exposed to intraoperative hypotension after spinal anesthesia and we proposed that intravenous Granisterone 1 mg will attenuate the hypotension occurred with spinal block during Cesarean sections.

Condition or disease Intervention/treatment Phase
Spinal-induced Hypotension Drug: Granisetron 0.1 MG/ML Drug: Placebos Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Attenuation of Spinal Induced Hypotension With Granisetron in Type I Diabetic Parturients
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Granisetron

Arm Intervention/treatment
Active Comparator: Granisetron group
patients in this group will receive intravenous Granisetron 0.1 MG/ML 10 minutes before spinal anesthesia
Drug: Granisetron 0.1 MG/ML
Granisetron 0.1 MG/ML Will be given 10 min before spinal block
Other Name: Granisetron

Placebo Comparator: Placebo group
Patients in this group will receive 10 ml normal saline as placebos considering the same timing and color of solution
Drug: Placebos
Placebos will be given 10 min before spinal block
Other Name: Placebo




Primary Outcome Measures :
  1. Incidence of Hypotension [ Time Frame: 15 minutes after spinal anesthesia ]
    incidence of hypotension with systolic blood pressure less than 90 mmHg


Secondary Outcome Measures :
  1. Incidence of bradycardia [ Time Frame: 15 minutes after spinal anesthesia ]
    Incidence of bradycardia with Heart Rate less than 50 beats / minutes



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type I diabetic patients
  • Parturients presented for Cesarean section

Exclusion Criteria:

  • Contraindications for spinal anesthesia (like bleeding diathesis or regional infection at site of neuroaxial block)
  • Known allergy to Granisetron or local anaesthetic (heavy bupivacaine, Marcaine Spinal 0.5% Heavy, 5mg/ml, AstraZeneca ampule)
  • Pregnancy induced hypertension
  • Congenital or rheumatic heart diseases
  • Antepartum haemorrhage
  • Fetal destress or gestational age < 36 week

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): NCT03091881


Contacts
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Contact: Mohamed Elsadany, M.D 00201097973797 mohamed_elsadany@med.suez.edu.eg
Contact: Amr Helmy, M.D 00201223486345 helmyamr2000@yahoo.com

Locations
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Egypt
Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department Recruiting
Ismailia, Egypt, 41522
Contact: Amgad Matar, M.D    0020643230539    med_dean@suez.edu.eg   
Sub-Investigator: Mohamed A Elsadany, M.D         
Principal Investigator: Amr M Helmy, M.D         
Principal Investigator: Emad E Ahmed, M.D         
Principal Investigator: Abdelrhman Elshawadfy, M.D         
Sponsors and Collaborators
Suez Canal University
Investigators
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Study Director: Mohamed A Elsadany, M.D Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department
Study Director: Amr M Helmy, M.D Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department
Principal Investigator: Emad E Ahmed, M.D Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department
Principal Investigator: Abdelrhman Alshawadfy, M.D Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department

Publications:
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Responsible Party: Mohamed A Elsadany, MD, Lecturer of anesthesiology, Suez Canal University
ClinicalTrials.gov Identifier: NCT03091881     History of Changes
Other Study ID Numbers: 2978
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohamed A Elsadany, MD, Suez Canal University:
Granisetron
Spinal induced hypotension
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action