Intrathecal Dexmedetomidine vs Epinephrine

NCT06418308 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY-23-01613
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Cesarean Section; Anesthesia, Spinal

Keywords

Cesarean Section; Spinal Anesthesia; Intrathecal adjuncts; Dexmedetomidine; Epinephrine

Outcome Measures

Primary Outcomes (1)

• Time required for sensory recovery

  Investigate the efficacy of intrathecal epinephrine versus dexmedetomidine as adjuvant agents in cesarean section. Once the sensory block to pinprick has receded to a T10 level, the spinal is no longer as effective for surgical level pain relief. This is a measure of the duration of the spinal as an effective analgesic. Sensory recovery will be a T10 level. This will be measured in minutes.

  270 minutes

Secondary Outcomes (26)

• Time to Bromage Score 1

  270 minutes

• Blood Pressure

  30 minutes

• Phenylephrine Infusion Rate

  2 to 30 minutes

• Total Phenylephrine Infusion

  during surgery which can go up to 150 minutes

• Number of Phenylephrine Boluses

  during surgery which can go up to 150 minutes

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine; Drug: Standardized Spinal Mixture

Epinephrine

ACTIVE COMPARATOR

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

Drug: Epinephrine; Drug: Standardized Spinal Mixture

Interventions

Dexmedetomidine DRUG

5 mcg of dexmedetomidine

Dexmedetomidine

Epinephrine DRUG

200 mcg of epinephrine

Epinephrine

Standardized Spinal Mixture DRUG

Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.

Dexmedetomidine; Epinephrine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant patients
• aged 18-55 years
• presenting for scheduled primary or secondary cesarean section
• candidates for single shot spinal anesthesia singleton pregnancy

You may not qualify if:

• 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
• BMI \> 40

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Epinephrine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Daniel Katz, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Talia Scott, MD

CONTACT

720-212-7448; talia.scott@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Education Department of Anesthesiology, Pain, & Perioperative Medicine

Model Details: 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, and 0.125 mg morphine.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: September 17, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)