Intrathecal Dexmedetomidine vs Epinephrine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section

NCT04464616

Postoperative Pain

COMPLETED NA

Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia

NCT04358367

Cesarean Section Complications

COMPLETED PHASE3

Dexamethasone and Dexmedetomidine as an Adjuvant to Spinal Anesthesia for Elective Caesarean Sections

NCT04697745

Pain, Postoperative

UNKNOWN NA

Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery

NCT05342844

Analgesia

COMPLETED NA

Dexamethasone Intravenous Versus Intrathecal in Spinal Anesthesia

NCT05470530

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section Anesthesia, Spinal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

5 mcg of dexmedetomidine

Standardized Spinal Mixture

Intervention Type DRUG

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

Epinephrine

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

Group Type ACTIVE_COMPARATOR

Epinephrine

Intervention Type DRUG

200 mcg of epinephrine

Standardized Spinal Mixture

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

5 mcg of dexmedetomidine

Intervention Type DRUG

Epinephrine

200 mcg of epinephrine

Intervention Type DRUG

Standardized Spinal Mixture

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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
* BMI \> 40

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No