## Protocol Section
### Identification Module
**NCT ID:** NCT06423807

**Brief Title:** Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section

**Official Title:** Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 36264PR642/4/24
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tanta University

#### Responsible Party

**Investigator Affiliation:** Tanta University

**Investigator Full Name:** Mohammed Said ElSharkawy

**Investigator Title:** Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.

**Detailed Description:** Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.

Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.

Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.

### Conditions Module

**Conditions:**

- Ondansetron Lozenge

- Post-Spinal Shivering

- Cesarean Section

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group.

**Intervention Names:**

- Drug: Ondansetron lozenge

**Label:** Group S (Ondansetron lozenge)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients will not receive ondansetron as a control group.

**Label:** Group C (Control)

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group S (Ondansetron lozenge)

**Description:** Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.

**Name:** Ondansetron lozenge

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Shivering will be graded during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan and Tsai and Chu.

0=No shivering, 1=Piloerection or peripheral vasoconstriction but no visible shivering, 2=Muscular activity in only one muscle group, 3=Muscular activity in more than one muscle group but not generalized shivering, 4=Shivering involving the whole body.

Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby.

**Measure:** Incidence of shivering

**Time Frame:** 24 hours postoperatively

#### Secondary Outcomes

**Description:** The incidence of nausea and vomiting will be evaluated through the Bellville scoring scale (lack of nausea and vomiting=0, nausea=1, nausea with belching=2, and vomiting=3).

**Measure:** Incidence of postoperative nausea and vomiting (PONV)

**Time Frame:** 24 hours postoperatively

**Description:** • Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

**Measure:** Patients' satisfaction

**Time Frame:** 24 hours postoperatively

**Description:** Adverse events such as bradycardia, hypotension, respiratory depression, or any other complication will be recorded.

**Measure:** Adverse effects

**Time Frame:** 24 hours postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age from 18 to 40 years.
* American Society of Anesthesiology (ASA) physical status II.
* Parturient women undergoing CS under spinal anesthesia.

Exclusion Criteria:

* Parturient women with any contraindication or hypersensitivity to the study drugs.
* Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial.
* Temperature more than 38°C or less than 36°C.
* Body Mass Index (BMI)\> 40 kg/m2.
* Medical history of alcohol or drug abuse.
* Parkinson's disease or any extrapyramidal disease.
* Intraoperative blood transfusion.
* History of chemotherapy treatment.

**Gender Based:** True

**Gender Description:** Parturient women undergoing cesarean section under spinal anesthesia

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mselsharkawy@med.tanta.edu.eg

**Name:** Mohammed S Elsharkawy, MD

**Phone:** 00201148207870

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tanta

**Contacts:**

***Contact 1:***

- **Email:** mselsharkawy@med.tanta.edu.eg

- **Name:** Mohammed S Elsharkawy, MD

- **Phone:** 00201148207870

- **Role:** CONTACT

***Contact 2:***

- **Name:** Saad A Moharam, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Tanta University

**State:** El-Gharbia

**Status:** RECRUITING

**Zip:** 31527

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Medicine Tanta University, Egypt

**Name:** Mohammed S Elsharkawy, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** The data will be available upon a reasonable request from the corresponding author.

**Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After the end of study for one year.

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000000982

- Term: Antipruritics

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000058831

- Term: Serotonin 5-HT3 Receptor Antagonists

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### 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

### Intervention Browse Module - Browse Leaves

- ID: M19588

- Name: Ondansetron

- Relevance: HIGH

- As Found: Dual

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M29246

- Name: Serotonin 5-HT3 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017294

- Term: Ondansetron

### Misc Info Module

- Version Holder: 2024-05-31
