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Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery

NCT ID: NCT06437236

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2024-12-01

Brief Summary

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Spinal anesthesia is commonly used in cesarean section surgeries . The most important adverse effects of spinal anesthesia are hypotension and bradycardia caused by sympathetic blockade, with an incidence of about 55-100% . However, blocking the venous return by the gravid uterus increases the risk of hypotension. Spinal anesthesia-induced hypotension is commonly associated with uncomfortable symptoms, such as shivering , nausea and vomiting, in the mother. Prolonged maternal hypotension may lead to serious maternal adverse effects, such as cardiovascular collapse, loss of consciousness, apnea, and aspiration of gastric contents. In addition, uteroplacental blood flow decreases in cases of sustained hypotension and detrimental neonatal effects, such as fetal acidosis and fetal death, may occur. Preventing spinal anesthesia-induced hypotension during cesarean section is essential for the well-being of both the mother and neonate.

Also, Shivering often happens after spinal anesthesia. Shivering is an unconscious and rhythmic movement involving several groups of muscles. The increase of muscle activity generates the elevation of oxygen consumption, lactic acidosis, and carbon dioxide production In recent years, researchers have focused on the effects of the Bezold-Jarisch reflex (BJR) . This reflex includes a triad of bradycardia, hypotension, and apnea. Researchers have suggested that serotonin and 5-hydroxytryptamine 3 (5-HT3) receptors play an important role in the occurrence of the BJR after spinal anesthesia . The 5-HT3 receptors are present in the heart, lung, and spine. Diminished venous return caused by spinal anesthesia stimulates the cardiac chemoreceptors, and parasympathetic activity increases, which results in bradycardia and hypotension . Studies have suggested that the use of 5-HT3 antagonists may attenuate spinal anesthesia-induced hypotension, thus inhibiting peripheral vasodilatation, alleviating the BJR, and increasing venous return to the heart . Ondansetron is a commonly used 5-HT3 receptor antagonist, and its peak plasma concentration occurs within 30 min following IV injection. Granisetron is a new 5-HT3 receptor antagonist, and the onset of action occurs 30 min following its IV administration \[

Detailed Description

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Conditions

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Hemodynamic Instability and Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block.

Group Type ACTIVE_COMPARATOR

ondansetron

Intervention Type DRUG

Group A will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block

group B

will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block.

Group Type ACTIVE_COMPARATOR

granisetron

Intervention Type DRUG

Group B will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block

Interventions

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ondansetron

Group A will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block

Intervention Type DRUG

granisetron

Group B will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL.

After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All parturient who underwent elective caesarean delivery under spinal anesthesia will be included in this study

Exclusion Criteria

* 1\. Patient refusal 2. Patient with significant neurological , psychological disease 3. patient known allergy to ondansetron or granisetron, 4. patients receiving serotonin agonists or antagonists, 5. patient ischemic heart disease, chronic hypertension or pregnancy induced hypertension
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdelrady Abdelaziz

resident at Anesthesiology, Surgical Intensive Care and Pain Medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed A A, resident

Role: CONTACT

Phone: 01030026022

Email: [email protected]

fawzy A B, assistant professor

Role: CONTACT

References

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Lee JE, George RB, Habib AS. Spinal-induced hypotension: Incidence, mechanisms, prophylaxis, and management: Summarizing 20 years of research. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):57-68. doi: 10.1016/j.bpa.2017.01.001. Epub 2017 Jan 8.

Reference Type BACKGROUND
PMID: 28625306 (View on PubMed)

Kinsella SM, Tuckey JP. Perioperative bradycardia and asystole: relationship to vasovagal syncope and the Bezold-Jarisch reflex. Br J Anaesth. 2001 Jun;86(6):859-68. doi: 10.1093/bja/86.6.859.

Reference Type BACKGROUND
PMID: 11573596 (View on PubMed)

Ortiz-Gomez JR, Palacio-Abizanda FJ, Morillas-Ramirez F, Fornet-Ruiz I, Lorenzo-Jimenez A, Bermejo-Albares ML. The effect of intravenous ondansetron on maternal haemodynamics during elective caesarean delivery under spinal anaesthesia: a double-blind, randomised, placebo-controlled trial. Int J Obstet Anesth. 2014 May;23(2):138-43. doi: 10.1016/j.ijoa.2014.01.005. Epub 2014 Feb 4.

Reference Type BACKGROUND
PMID: 24631057 (View on PubMed)

Yeoh SB, Leong SB, Heng AS. Anaesthesia for lower-segment caesarean section: Changing perspectives. Indian J Anaesth. 2010 Sep;54(5):409-14. doi: 10.4103/0019-5049.71037.

Reference Type BACKGROUND
PMID: 21189878 (View on PubMed)

Other Identifiers

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soh-Med-24-04-012MS

Identifier Type: -

Identifier Source: org_study_id