Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

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

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-02-01

Brief Summary

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The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.

Detailed Description

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Ondansetron has been reported to attenuate the incidence of spinal anaesthesia-induced hypotension (SAIH) and norepinephrine requirement during caesarean section.

The mechanism of hypotension following spinal anaesthesia involves the reduction in vascular resistance caused by the sympathetic block and the activation of the Bezold-Jarisch reflex, leading to vasodilation and hypotension. Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are required for the activation of the Bezold-Jarisch reflex. In a rabbit model, a 5-HT3 receptor antagonist was reported to suppress bradycardia and hypotension by preventing the Bezold-Jarisch reflex.

Conditions

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Spinal Anaesthesia Induced Hypotension

Keywords

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Ondansetron Spinal anaethesia Hypotension Norepinephrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ondansetron (Zofran)

Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot

Group Type ACTIVE_COMPARATOR

Ondansetron (Zofran)

Intervention Type DRUG

Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot.

Saline placebo

Normal saline will be administered by intravenous infusion 10 minutes before spinal anaesthesia

Group Type PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type DRUG

normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia

Interventions

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Ondansetron (Zofran)

Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot.

Intervention Type DRUG

Saline (NaCl 0,9 %) (placebo)

normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age from 19 to 40 years old.
* Singleton pregnancies with a gestational age of at least 37 weeks.
* pregnant women are scheduled for elective caesarean delivery.
* Patients with stable vital signs.
* Patients with normal laboratory investigations.
* patients undergoing spinal anaesthesia for caesarean delivery via Pfannenstiel incision with exteriorizaion of the uterus.

Exclusion Criteria

* Patient's refusal.
* Age \< 19 or \> 40 years.
* Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
* Contraindications to spinal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
* Patients with cardiac morbidities.
* hypertensive disorders of pregnancy as pre-eclampsia.
* peripartum bleeding.
* Patients with respiratory morbidities.
* Convulsions.
* Bleeding diathesis.
* Known allergy to any drugs used in this study.

Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Waleed Tarek Farouk

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed H Bakri, professor

Role: STUDY_DIRECTOR

Assiut University

Ola M Wahba, A.professor

Role: STUDY_DIRECTOR

Assiut University

Abdelrahman H Mohammed, A.professor

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Waleed T Farouk, Resident

Role: CONTACT

Phone: +2001150903140

Email: [email protected]

Facility Contacts

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Vice president of graduate studies of assiut university

Role: primary

References

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Sheng ZM, Sun HQ, Mao JQ, Liu J, Liang G, Mei Z. Comparative dose-response study on the infusion of norepinephrine combined with intravenous ondansetron versus placebo for preventing hypotension during spinal anesthesia for cesarean section: a randomised controlled trial. Int J Surg. 2024 Feb 1;110(2):832-838. doi: 10.1097/JS9.0000000000000920.

Reference Type RESULT

PMID: 38000073 (View on PubMed)

Other Identifiers

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