Cesarean SectionPhase 4NCT06418308
Intrathecal Dexmedetomidine vs Epinephrine
A Phase 4 study testing Dexmedetomidine, Epinephrine and Standardized Spinal Mixture in people with Cesarean Section and Anesthesia, Spinal, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Cesarean Section, Anesthesia, Spinal
- What is being tested?
- Dexmedetomidine, Epinephrine and Standardized Spinal Mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2024to 21 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients
- aged 18-55 years
- presenting for scheduled primary or secondary cesarean section
- candidates for single shot spinal anesthesia singleton pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section
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
- Being tested
- Dexmedetomidine, Epinephrine, Standardized Spinal Mixture
- Keywords
- Cesarean Section, Spinal Anesthesia, Intrathecal adjuncts, Dexmedetomidine, Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
5 mcg of dexmedetomidine
EpinephrineDrug
200 mcg of epinephrine
Standardized Spinal MixtureDrug
Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture. Receives: Drug: Dexmedetomidine; Drug: Standardized Spinal Mixture |
| Epinephrine | Active comparator | receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture Receives: Drug: Epinephrine; Drug: Standardized Spinal Mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 270 minutes
Secondary outcomes (26)
Time to Bromage Score 1
Time to motor recovery determines how long the patient will be in the post anesthesia care unit. This will be measured in minutes. Bromage Scale to determine recovery where recovery will be Bromage 1.
Bromage Scale:
Bromage 0 full flexion knees and feet
Bromage 1 just able to move knees
Bromage 2 able to move feet only
Bromage 3 unable to move feet or knees
Measured: 270 minutes
Blood Pressure
Systolic and Diastolic Blood pressures will be measured preoperatively and then every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement.
Measured: 30 minutes
Phenylephrine Infusion Rate
the phenylephrine infusion rate from 2 to 30 minutes after spinal placement
Measured: 2 to 30 minutes
Total Phenylephrine Infusion
the total phenylephrine infusion given during surgery.
Measured: during surgery which can go up to 150 minutes
Number of Phenylephrine Boluses
Number of Phenylephrine Boluses given during the operation
Measured: during surgery which can go up to 150 minutes
Number of Ephedrine Boluses
Number of Ephedrine Boluses given during the operation
Measured: during surgery which can go up to 150 minutes
Number of Nausea episodes
Nausea will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.
Measured: 60 minutes
Number of Vomiting episodes
Vomiting will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.
Measured: 60 minutes
Number of Shivering episodes
Shivering will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.
Measured: 60 minutes
Number of Pruritus episodes
Pruritus will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.
Measured: 60 minutes
Pain Score at Skin Incision
Pain scores at time of skin incision. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).
Measured: within the surgery, which can go up to 150 minutes
Pain Score at Uterine Incision
Pain scores at time of uterine incision. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).
Measured: within the surgery, which can go up to 150 minutes
Pain Score at Uterine Exteriorization
Pain scores at time of uterine exteriorization. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).
Measured: within the surgery, which can go up to 150 minutes
Pain Score at Uterine Closure
Pain scores at time of uterine closure. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).
Measured: within the surgery, which can go up to 150 minutes
Pain Score at Gutter Cleaning
Pain scores at time of gutter cleaning. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).
Measured: within the surgery, which can go up to 150 minutes
Pain Score at Procedure Finish
Pain scores at time of procedure finish . Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).
Measured: at procedure finish, which can go up to 150 minutes
Additional IV Medication
Any additional IV medications that need to be given during the surgery will be recorded (e.g. IV fentanyl).
Measured: during surgery which can go up to 150 minutes
Number of participants who require Conversion to General Anesthesia
Number of participants who require Conversion to General Anesthesia. If converted to general anesthesia, enrollment in study will end.
Measured: during surgery which can go up to 150 minutes
Heart Rate
Heart rate will be measured every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement.
Measured: total of 30 minutes from the time of spinal placement.
Oxygen Saturation
Oxygen saturation will be measured every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement.
Measured: total of 30 minutes from the time of spinal placement.
Apgar Scores
Neonatal Apgar Scores at 1 and 5 minutes will be recorded. Apgar score ranges from 0 to 10, with higher score indicating better health outcomes.
Measured: 1 minute and 5 minutes
Number of NICU admission
Number of babies that require Neonatal Intensive Care Unit (NICU) admission from the OR.
Measured: Day 1
Patient Satisfaction Score
Patient will be asked to score satisfaction postoperatively Patient Satisfaction Score
- Completely dissatisfied
- Partially dissatisfied
- Neutral
- Partially satisfied
- Completely satisfied
Measured: Post-Op Day 1
Time to First opioid
Via chart review, time to first opioid within a 24 hour time period after spinal placement.
Measured: 24 hours
Total Opioid Dose
Via chart review, time to total opioids given within a 24 hour time period after spinal placement.
Measured: 24 hours
Time to sensory block
Spinal Onset - The T4 sensory level is considered adequate for operative analgesia for cesarean delivery. Time to a sensory block to pinprick to T4 level over a 20 minute time period after spinal placement will be recorded. If T4 not reached, highest level achieved will be recorded. This will be measured in minutes.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start17 Sep 2024
- Primary completion20 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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, and 0.125 mg morphine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418308
- Sponsor's protocol ID
- STUDY-23-01613
- Status last verified
- Jan 2026
- First submitted
- 13 May 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan in place to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section
- ClinicalTrials.gov ID
- NCT06418308
- Acronym / sponsor ID
- STUDY-23-01613
- Conditions
- Cesarean Section, Anesthesia, Spinal
- Keywords
- Cesarean Section, Spinal Anesthesia, Intrathecal adjuncts, Dexmedetomidine, Epinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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, and 0.125 mg morphine.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine, Drug: Standardized Spinal Mixturereceiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture. |
| Epinephrine | Active comparator | Drug: Epinephrine, Drug: Standardized Spinal Mixturereceiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant patients
- aged 18-55 years
- presenting for scheduled primary or secondary cesarean section
- candidates for single shot spinal anesthesia singleton pregnancy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine5 mcg of dexmedetomidine | Drug | Dexmedetomidine |
| Epinephrine200 mcg of epinephrine | Drug | Epinephrine |
| Standardized Spinal MixtureStandardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine. | Drug | Dexmedetomidine, Epinephrine |
Primary outcome
Time required for sensory recovery
Time frame: 270 minutes
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.
26 secondary outcomes
Time to Bromage Score 1
Time frame: 270 minutes
Blood Pressure
Time frame: 30 minutes
Phenylephrine Infusion Rate
Time frame: 2 to 30 minutes
Total Phenylephrine Infusion
Time frame: during surgery which can go up to 150 minutes
Number of Phenylephrine Boluses
Time frame: during surgery which can go up to 150 minutes
Number of Ephedrine Boluses
Time frame: during surgery which can go up to 150 minutes
Number of Nausea episodes
Time frame: 60 minutes
Number of Vomiting episodes
Time frame: 60 minutes
Number of Shivering episodes
Time frame: 60 minutes
Number of Pruritus episodes
Time frame: 60 minutes
Pain Score at Skin Incision
Time frame: within the surgery, which can go up to 150 minutes
Pain Score at Uterine Incision
Time frame: within the surgery, which can go up to 150 minutes
Pain Score at Uterine Exteriorization
Time frame: within the surgery, which can go up to 150 minutes
Pain Score at Uterine Closure
Time frame: within the surgery, which can go up to 150 minutes
Pain Score at Gutter Cleaning
Time frame: within the surgery, which can go up to 150 minutes
Pain Score at Procedure Finish
Time frame: at procedure finish, which can go up to 150 minutes
Additional IV Medication
Time frame: during surgery which can go up to 150 minutes
Number of participants who require Conversion to General Anesthesia
Time frame: during surgery which can go up to 150 minutes
Heart Rate
Time frame: total of 30 minutes from the time of spinal placement.
Oxygen Saturation
Time frame: total of 30 minutes from the time of spinal placement.
Apgar Scores
Time frame: 1 minute and 5 minutes
Number of NICU admission
Time frame: Day 1
Patient Satisfaction Score
Time frame: Post-Op Day 1
Time to First opioid
Time frame: 24 hours
Total Opioid Dose
Time frame: 24 hours
Time to sensory block
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan in place to share IPD.
Related trials for Cesarean Section
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Katz, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Epinephrine and Standardized Spinal Mixture in people with Cesarean Section and Anesthesia, Spinal, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for sensory recovery (time frame: 270 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.