Granisetron in Diabetic Parturients Decrease Spinal Induced Hypotension
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ClinicalTrials.gov Identifier: NCT03091881 |
Recruitment Status : Unknown
Verified June 2018 by Mohamed A Elsadany, MD, Suez Canal University.
Recruitment status was: Recruiting
First Posted : March 27, 2017
Last Update Posted : July 2, 2018
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Condition or disease | Intervention/treatment | Phase |
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Spinal-induced Hypotension | Drug: Granisetron 0.1 MG/ML Drug: Placebos | Phase 4 |

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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Granisetron group
patients in this group will receive intravenous Granisetron 0.1 MG/ML 10 minutes before spinal anesthesia
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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
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Drug: Placebos
Placebos will be given 10 min before spinal block
Other Name: Placebo |
- Incidence of Hypotension [ Time Frame: 15 minutes after spinal anesthesia ]incidence of hypotension with systolic blood pressure less than 90 mmHg
- 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 |
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

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
Contact: Mohamed Elsadany, M.D | 00201097973797 | mohamed_elsadany@med.suez.edu.eg | |
Contact: Amr Helmy, M.D | 00201223486345 | helmyamr2000@yahoo.com |
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 |
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 |
Responsible Party: | Mohamed A Elsadany, MD, Lecturer of anesthesiology, Suez Canal University |
ClinicalTrials.gov Identifier: | NCT03091881 |
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 |
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 |
Granisetron Spinal induced hypotension |
Hypotension Vascular Diseases Cardiovascular Diseases Granisetron Antiemetics Autonomic Agents Peripheral Nervous System Agents |
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