## Protocol Section
### Identification Module
**NCT ID:** NCT06418308

**Brief Title:** Intrathecal Dexmedetomidine vs Epinephrine

**Official Title:** Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section

#### Organization Study ID Info
**ID:** STUDY-23-01613
#### Organization
**Class:** OTHER
**Full Name:** Icahn School of Medicine at Mount Sinai
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Icahn School of Medicine at Mount Sinai

#### Responsible Party

**Investigator Affiliation:** Icahn School of Medicine at Mount Sinai

**Investigator Full Name:** Daniel Katz

**Investigator Title:** Vice Chair of Education Department of Anesthesiology, Pain, & Perioperative Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section.

### Conditions Module

**Conditions:**

- Cesarean Section

- Anesthesia, Spinal

**Keywords:**

- Cesarean Section

- Spinal Anesthesia

- Intrathecal adjuncts

- Dexmedetomidine

- Epinephrine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Patients will be randomized to either receiving the addition of epinephrine or dexmedetomidine to the standard spinal medication mixture of 10.25 mg hyperbaric bupivacaine, 12.5 mcg fentanyl, and 0.125 mg morphine.

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** Patients will be assigned a group by picking from a stack of envelopes. The interventional drug which the envelope contains will be assigned by a random number generator. The interventional drug will be drawn up by an anesthesiologist not involved in the patient's care and the syringe given to the anesthesiologist performing the spinal anesthetic.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture.

**Intervention Names:**

- Drug: Dexmedetomidine

- Drug: Standardized Spinal Mixture

**Label:** Dexmedetomidine

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture

**Intervention Names:**

- Drug: Epinephrine

- Drug: Standardized Spinal Mixture

**Label:** Epinephrine

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dexmedetomidine

**Description:** 5 mcg of dexmedetomidine

**Name:** Dexmedetomidine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Epinephrine

**Description:** 200 mcg of epinephrine

**Name:** Epinephrine

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Dexmedetomidine

- Epinephrine

**Description:** Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, 12.5 mcg fentanyl, and 0.125 mg morphine.

**Name:** Standardized Spinal Mixture

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Time required for sensory recovery at T10 to investigate the efficacy of adjuvant agents in cesarean section. Once the sensory block has receded to a T10 level, the spinal is no longer as effective for surgical level anesthesia. This will be measured in minutes.

**Measure:** Time required for sensory recovery at T10

**Time Frame:** 360 minutes

#### Secondary Outcomes

**Description:** Time to motor recovery determines how long the patient will be in the post anesthesia care unit.

**Measure:** Time to motor and sensory recovery

**Time Frame:** 480 minutes

**Description:** The speed of sensory regression determines how long the spinal will be effective.

**Measure:** Time to sensory recovery

**Time Frame:** 480 minutes

**Description:** The time to first postoperative analgesic gives information on how adequately pain is controlled postoperatively.

**Measure:** Time to administration of postoperative analgesic

**Time Frame:** 24 hours

**Description:** The use of intravenous opioid agents such as fentanyl or morphine during the cesarean section can demonstrate that the spinal is not adequate for surgical anesthesia and analgesia. Any use of intravenous opioid administered during cesarean section is indicative of inadequate analgesia and the number of participants receiving this will be reported

**Measure:** Number of participants receiving intravenous opioid

**Time Frame:** 360 minutes

**Description:** The onset time of the block can determine its feasibility in urgent situations where there is a time limit in which the surgeon must begin the operation.

**Measure:** Time required to achieve T4 anesthetic level

**Time Frame:** 60 minutes

**Description:** Incidence of intraoperative hypotension, nausea, vomiting, shivering, and pruritis. Unfavorable side effects should be assessed as they affect patient experience. These are potential side effects from the spinal anesthesia itself and the normal mixture of bupivacaine, morphine, and fentanyl.

**Measure:** Incidence of specific side effects

**Time Frame:** 360 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pregnant patients aged 18-55 years who are presenting for scheduled cesarean section and are candidates for single shot spinal anesthesia for cesarean section.

Exclusion Criteria:

* Patient refusal of spinal anesthetic
* If patient is not a candidate for spinal anesthesia due to history of coagulopathy, elevated intracranial pressure, infection at site of injection, etc.
* Emergency cesarean section
* Preexisting motor or sensory deficit
* Suspected pre-eclampsia
* Patient receiving combined spinal-epidural as anesthetic technique

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** talia.scott@mountsinai.org

**Name:** Talia Scott, MD

**Phone:** 720-212-7448

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** talia.scott@mountsinai.org

- **Name:** Talia Scott, MD

- **Phone:** 720-212-7448

- **Role:** CONTACT

***Contact 2:***

- **Name:** Daniel Katz

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Mount Sinai Hospital

**State:** New York

**Zip:** 10029

#### Overall Officials

**Official 1:**

**Affiliation:** Icahn School of Medicine at Mount Sinai

**Name:** Daniel Katz, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** There is no plan in place to share IPD.

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000318

- Term: Adrenergic beta-Agonists

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000009184

- Term: Mydriatics

- ID: D000013566

- Term: Sympathomimetics

- ID: D000014662

- Term: Vasoconstrictor Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M8418

- Name: Fentanyl

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M11982

- Name: Morphine

- Relevance: LOW

- As Found: Unknown

- ID: M7992

- Name: Epinephrine

- Relevance: HIGH

- As Found: Growth

- ID: M30371

- Name: Racepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M211043

- Name: Epinephryl borate

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3670

- Name: Adrenergic beta-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12139

- Name: Mydriatics

- Relevance: LOW

- As Found: Unknown

- ID: M16345

- Name: Sympathomimetics

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004837

- Term: Epinephrine

- ID: D000020927

- Term: Dexmedetomidine

### Misc Info Module

- Version Holder: 2024-05-31
