Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section
Study Details
Study Description
Brief Summary
Cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. Although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. Cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. Among cardiac diseases, Rheumatic Heart Disease is the commonest cardiac disease complicating pregnancy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group G IV granisetron 1mg |
Drug: Granisetron Hydrochloride
IV granisetron 1mg
Other Names:
|
| Placebo Comparator: Group C IV 5ml of 0.9% normal saline |
Other: 0.9% normal saline
IV 5ml of 0.9% normal saline
Other Names:
|
Outcome Measures
Primary Outcome Measures
- post-spinal hypotension, and bradycardia [24 hours postoperative]
post-spinal hypotension, and bradycardia in rheumatic patients undergoing elective cesarean section
Eligibility Criteria
Criteria
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,
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coagulation abnormalities,
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vertebral deformities, also patients who refused regional anesthesia,
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having contraindications to spinal anesthesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assiut governorate | Assiut | Egypt | 715715 |
Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- Granisetron