Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section
Primary Purpose
Granisetron
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Granisetron Hydrochloride
0.9% normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Granisetron
Eligibility 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,
- coagulation abnormalities,
- vertebral deformities, also patients who refused regional anesthesia,
- having contraindications to spinal anesthesia
Sites / Locations
- Assiut governorateRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group G
Group C
Arm Description
IV granisetron 1mg
IV 5ml of 0.9% normal saline
Outcomes
Primary Outcome Measures
post-spinal hypotension, and bradycardia
post-spinal hypotension, and bradycardia in rheumatic patients undergoing elective cesarean section
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05314257
Brief Title
Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section
Official Title
Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granisetron
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group G
Arm Type
Active Comparator
Arm Description
IV granisetron 1mg
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
IV 5ml of 0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
Granisetron Hydrochloride
Other Intervention Name(s)
granisetron
Intervention Description
IV granisetron 1mg
Intervention Type
Other
Intervention Name(s)
0.9% normal saline
Other Intervention Name(s)
normal saline
Intervention Description
IV 5ml of 0.9% normal saline
Primary Outcome Measure Information:
Title
post-spinal hypotension, and bradycardia
Description
post-spinal hypotension, and bradycardia in rheumatic patients undergoing elective cesarean section
Time Frame
24 hours postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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,
coagulation abnormalities,
vertebral deformities, also patients who refused regional anesthesia,
having contraindications to spinal anesthesia
Facility Information:
Facility Name
Assiut governorate
City
Assiut
ZIP/Postal Code
715715
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada M Aboelfadl, MD
Phone
01005802086
Email
ghadafadl77@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33489528
Citation
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.
Results Reference
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PubMed Identifier
29416149
Citation
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.
Results Reference
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PubMed Identifier
34508429
Citation
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.
Results Reference
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Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section
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