## Protocol Section
### Identification Module
**NCT ID:** NCT06428084

**Brief Title:** Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing PONV

**Official Title:** Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** AN-202405.01
#### Organization
**Class:** OTHER
**Full Name:** Universitas Padjadjaran
### Status Module
#### Completion Date
**Date:** 2024-02-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-28

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitas Padjadjaran

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Nausea and vomiting following laparoscopic cholecystectomy remain common, with occurrence rates of 40-70% during the initial 24 hours post-operation. The underlying mechanisms of postoperative nausea and vomiting engage five distinct neurotransmitter receptors. Consequently, employing a combination of antiemetics from diverse classes that target various receptors for effective prevention is advised. Ondansetron's antiemetic properties derive from its ability to inhibit serotonin receptors, whereas Haloperidol targets dopamine receptors, and Dexamethasone reduces prostaglandin production.

**Detailed Description:** Postoperative nausea and vomiting (PONV) are also known as the little problem interpreted as a seemingly less significant complication but lead to increased morbidity, longer hospital stays, increased medical costs, and diminished patient satisfaction with healthcare services. These symptoms are reported more frequently than postoperative pain, making its prevention as important as postoperative pain management. In laparoscopic cholecystectomy, the occurrence of PONV can range from 40 - 70%, which is higher than the 33 - 49% observed in other types of surgeries under general anesthesia within the first 24 hours post-procedure. The mechanism of PONV is complex, involving multiple neurotransmitters. Targeted neurotransmitter receptors in the action of antiemetic drugs include muscarinic-1-acetylcholine (M1), dopamine-2 (D2), histamine-1 (H1), 5-Hydroxytryptamine-3-serotonin (5HT3), and neurokinin1-substance P (NK1) receptors. Based on this, the prevention of postoperative nausea and vomiting is recommended using a combination of various groups of antiemetics that work on different receptors. Studies have shown that combining different antiemetic classes is more effective than using a single agent. A meta-analysis study stated that dexamethasone, ondansetron, and droperidol are the most used types of antiemetics alone or in combination. Dexamethasone with a 5HT3 antagonist such as ondansetron is the most used antiemetic combination. Another viable option includes dexamethasone with Butypherone group drugs, such as droperidol, which acts as a D2 antagonist. However, droperidol was subject to FDA black box warnings in 2003 due to its association with arrhythmias caused by QT interval prolongation. Subsequent research has suggested haloperidol, another Butypherone group drug, as a safer alternative to droperidol.

### Conditions Module

**Conditions:**

- Laparoscopic Cholecystectomy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 19 participants in group O received 4 mg of ondansetron intravenously.

**Intervention Names:**

- Drug: Ondansetron

**Label:** Ondansetron

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 19 participants in group H received 1 mg of Haloperidol intravenously.

**Intervention Names:**

- Drug: Haloperidol

**Label:** Haloperidol

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ondansetron

**Description:** 4 mg of ondansetron intravenously

**Name:** Ondansetron

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Haloperidol

**Description:** 1 mg of Haloperidol intravenously

**Name:** Haloperidol

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Score 0 (No nausea, no vomiting); Score 1 (Nausea present, no vomiting); Score 2 (Nausea present, vomiting present); Score 3 (Vomiting \>2 episodes in 30 minutes)

**Measure:** Nausea and Vomiting Score

**Time Frame:** 24 hours post-operation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* aged 18 - 65 years
* ASA physical status 1 and 2
* Apfel score ≥2

Exclusion Criteria:

* a history of allergies
* routine use of antipsychotic drugs, steroids, antihistamines, and antiemetics before surgery
* cardiac rhythm disorders
* elevated liver enzyme levels (SGOT/SGPT) ≥5 times upper limit normal
* BMI ≥35 kg/m2

Dropout Criteria:

* if they experienced hypotension, defined as systolic blood pressure below 90 mmHg or mean arterial pressure (MAP) below 60 mmHg, or a decrease in systolic blood pressure and/or MAP greater than 20% from baseline for a duration exceeding two minutes, surgical procedures extending \>3 hours, and any alterations in the planned surgical intervention.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bandung

**Country:** Indonesia

**Facility:** Hasan Sadikin General Hospital

**State:** West Java

**Zip:** 40161

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Medicine Universitas Padjadjaran Bandung

**Name:** Dian Mardiani, M.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12273

- Name: Nausea

- Relevance: LOW

- As Found: Unknown

- ID: M17582

- Name: Vomiting

- Relevance: LOW

- As Found: Unknown

- ID: M22074

- Name: Postoperative Nausea and Vomiting

- Relevance: LOW

- As Found: Unknown

### 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

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

- ID: D000018726

- Term: Anti-Dyskinesia Agents

### 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: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnDyAg

- Name: Anti-Dyskinesia Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M19588

- Name: Ondansetron

- Relevance: HIGH

- As Found: Dual

- ID: M7102

- Name: Dexamethasone

- Relevance: LOW

- As Found: Unknown

- ID: M9312

- Name: Haloperidol

- Relevance: HIGH

- As Found: Window

- ID: M215475

- Name: Haloperidol decanoate

- Relevance: HIGH

- As Found: Window

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- 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

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000006220

- Term: Haloperidol

- ID: D000017294

- Term: Ondansetron

- ID: C000033563

- Term: Haloperidol decanoate

### Misc Info Module

- Version Holder: 2024-05-31
