- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05314257
Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section
Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The subarachnoid block is the most used anesthesia technique for conducting a cesarean section. The incidence of hypotension following this procedure is as high as 20-40% in pregnant patients. Similarly, bradycardia is also commonly associated with post-SAB, and the reported incidence is around 13%. Spinal anesthesia results in sympathetic block leading to a decrease in systemic vascular resistance and hypotension. Hypotension caused by subarachnoid block is physiologically compensated by an increase in heart rate. However, if vagus nerve-mediated Bezold-Jarisch reflex gets stimulated, then the cardiac autonomic balance gets shifted towards the parasympathetic nervous system leading to bradycardia, which further precipitates hypotension.
Levobupivacaine is a highly potent long-acting local anesthetic with a comparatively slow onset of action. Compared to bupivacaine, it has a lower tendency to block deactivated cardiac sodium and potassium channels with a more rapid rate of dissociation. It has reduced cardiac toxicity on overdose intravenous administration due to its faster protein binding rate. Plain levobupivacaine is isobaric to CSF. One of its advantages is that it has a more expectable spread. Several studies have revealed the reduced occurrence of various side effects (such as nausea, vomiting, bradycardia, and hypotension) when levobupivacaine compared with bupivacaine for spinal anesthesia used for cesarean delivery. It has been suggested to use 12.5-13.5mg levobupivacaine for effective spinal anesthesia for cesarean delivery.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Assiut, Egypt, 715715
- Recruiting
- Assiut governorate
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Contact:
- Ghada M Aboelfadl, MD
- Phone Number: 01005802086
- Email: ghadafadl77@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Rheumatic female patients in the childbearing period scheduled for elective cesarean sections
Exclusion Criteria:
- Patients with eclampsia and pre-eclampsia history,
- uncontrolled diabetes mellitus, morbid obesity,
- coagulation abnormalities,
- vertebral deformities, also patients who refused regional anesthesia,
- having contraindications to spinal anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group G
IV granisetron 1mg
|
IV granisetron 1mg
Other Names:
|
Placebo Comparator: Group C
IV 5ml of 0.9% normal saline
|
IV 5ml of 0.9% normal saline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-spinal hypotension, and bradycardia
Time Frame: 24 hours postoperative
|
post-spinal hypotension, and bradycardia in rheumatic patients undergoing elective cesarean section
|
24 hours postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chatterjee A, Gudiwada B, Mahanty PR, Kumar H, Nag DS, Ganguly PK, Shukla R. Effectiveness of Granisetron in Prevention of Hypotension Following Spinal Anaesthesia in Patients Undergoing Elective Caesarean Section. Cureus. 2020 Dec 16;12(12):e12113. doi: 10.7759/cureus.12113.
- Fakherpour A, Ghaem H, Fattahi Z, Zaree S. Maternal and anaesthesia-related risk factors and incidence of spinal anaesthesia-induced hypotension in elective caesarean section: A multinomial logistic regression. Indian J Anaesth. 2018 Jan;62(1):36-46. doi: 10.4103/ija.IJA_416_17.
- Sharma B, Koirala E, Regmi S, Dhungana J, Neupane BK, Bhattarai S. Rheumatic Heart Disease among Pregnant Women with Cardiac Diseases in a Tertiary Care Center of Nepal: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2021 May 25;59(237):468-472. doi: 10.31729/jnma.6177.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Granisetron
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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