## Protocol Section
### Identification Module
**NCT ID:** NCT06431568

**Acronym:** Ondansetron

**Brief Title:** Ondansetron Prior Spinal Anaesthesia

**Official Title:** Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)

#### Organization Study ID Info
**ID:** IRB0000871252
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
#### Secondary ID Infos
**Domain:** Maternity Hospital
**ID:** Kuwait MOH
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-02

**Type:** ACTUAL

#### Start Date
**Date:** 2023-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Kuwait Institute for Medical Specialization

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Abdelrady S Ibrahim, MD

**Investigator Title:** Professor of Anesthesia and ICU

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

**Detailed Description:** Hypothesis:

Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.

Aim:

Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

Objectives:

* Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not
* Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.

### Conditions Module

**Conditions:**

- Cesarean Section

**Keywords:**

- Spinal anesthesia, Cesarean section, Ondansetron

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 400

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**Description:** Pregnant patients undergoing elective caesarean section with no co-morbidities will receive intravenous ondansetron

**Label:** Intravenous Ondansetron for patients undergoing Cesarean section under spinal Anesthesia

### Outcomes Module

#### Primary Outcomes

**Description:** incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron

**Measure:** Blood Pressure

**Time Frame:** one hour

#### Secondary Outcomes

**Description:** Incidence of bradycardia after ondansetron

**Measure:** Heart rate

**Time Frame:** One hour

**Description:** Incidence of use of ephedrine or phenylpherine

**Measure:** Vasopressor

**Time Frame:** One hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pregnant patients undergoing elective caesarean section

Exclusion Criteria:

* Preeclampsia
* Eclampsia
* Hypertension
* Diabetes

**Gender Based:** True

**Gender Description:** Pregnant patients undergoing elective cesarean section with no co-morbidities before or during pregnancy period

**Healthy Volunteers:** True

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Pregnant patients undergoing elective caesarean section with no co-morbidities before or during pregnancy period, e.g. HTN, DM, PET or Eclampsia, will be recruited. Attempt will be made to include all eligible participants

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Assiut

**Country:** Egypt

**Facility:** Assiut university faculty of medicine

#### Overall Officials

**Official 1:**

**Affiliation:** Assiut University Faculty Of Medicine

**Name:** Abdelrady S Ibrahim, .M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Hofhuizen C, Lemson J, Snoeck M, Scheffer GJ. Spinal anesthesia-induced hypotension is caused by a decrease in stroke volume in elderly patients. Local Reg Anesth. 2019 Mar 4;12:19-26. doi: 10.2147/LRA.S193925. eCollection 2019.

**PMID:** 30881108

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5196

- Name: Bradycardia

- Relevance: LOW

- As Found: Unknown

- ID: M10072

- Name: Hypotension

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

### Intervention Browse Module - Browse Leaves

- ID: M19588

- Name: Ondansetron

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
