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

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Sponsor:

Information provided by (Responsible Party):

Mohamed A Elsadany, MD, Suez Canal University

Study Description

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

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Study Design

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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

MedlinePlus related topics: Low Blood Pressure

Drug Information available for: Granisetron

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications:

Butterworth J. Physiology of spinal anesthesia: what are the implications for management? Reg Anesth Pain Med. 1998 Jul-Aug;23(4):370-3; discussion 384-7. Review.

Adams VR, Valley AW. Granisetron: the second serotonin-receptor antagonist. Ann Pharmacother. 1995 Dec;29(12):1240-51. Review.

Ziegler D, Dannehl K, Mühlen H, Spüler M, Gries FA. Prevalence of cardiovascular autonomic dysfunction assessed by spectral analysis, vector analysis, and standard tests of heart rate variation and blood pressure responses at various stages of diabetic neuropathy. Diabet Med. 1992 Nov;9(9):806-14.

Pfeifer MA, Weinberg CR, Cook DL, Reenan A, Halter JB, Ensinck JW, Porte D Jr. Autonomic neural dysfunction in recently diagnosed diabetic subjects. Diabetes Care. 1984 Sep-Oct;7(5):447-53.

Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16.

Arndt JO, Bömer W, Krauth J, Marquardt B. Incidence and time course of cardiovascular side effects during spinal anesthesia after prophylactic administration of intravenous fluids or vasoconstrictors. Anesth Analg. 1998 Aug;87(2):347-54.

Rhodes VA, Watson PM, Johnson MH. Development of reliable and valid measures of nausea and vomiting. Cancer Nurs. 1984 Feb;7(1):33-41.

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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

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