Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section

NCT ID: NCT05314257

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-12-31

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.

Conditions

Granisetron

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group G

IV granisetron 1mg

Group Type: ACTIVE_COMPARATOR

Granisetron Hydrochloride

Intervention Type: DRUG

IV granisetron 1mg

Group C

IV 5ml of 0.9% normal saline

Group Type: PLACEBO_COMPARATOR

0.9% normal saline

Intervention Type: OTHER

IV 5ml of 0.9% normal saline

Interventions

Granisetron Hydrochloride

IV granisetron 1mg

Intervention Type: DRUG

0.9% normal saline

IV 5ml of 0.9% normal saline

Intervention Type: OTHER

Other Intervention Names

granisetron; normal saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut governorate

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Ghada M Aboelfadl, MD

Role: primary

ghadafadl77@gmail.com

01005802086

References

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.

Reference Type: BACKGROUND

PMID: 33489528 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29416149 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34508429 (View on PubMed)

Other Identifiers

Granisetron

Identifier Type: -

Identifier Source: org_study_id