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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture. |
|
| Epinephrine | Active Comparator | receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 5 mcg of dexmedetomidine |
| |
| Epinephrine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 270 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Katz, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
There is no plan in place to share IPD.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2026 | Jun 12, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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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.
| Drug |
200 mcg of epinephrine |
|
| Standardized Spinal Mixture | Drug | Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine. |
|
| 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. | 30 minutes |
| Phenylephrine Infusion Rate | the phenylephrine infusion rate from 2 to 30 minutes after spinal placement | 2 to 30 minutes |
| Total Phenylephrine Infusion | the total phenylephrine infusion given during surgery. | during surgery which can go up to 150 minutes |
| Number of Phenylephrine Boluses | Number of Phenylephrine Boluses given during the operation | during surgery which can go up to 150 minutes |
| Number of Ephedrine Boluses | Number of Ephedrine Boluses given during the operation | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 1 minute and 5 minutes |
| Number of NICU admission | Number of babies that require Neonatal Intensive Care Unit (NICU) admission from the OR. | Day 1 |
| Patient Satisfaction Score | Patient will be asked to score satisfaction postoperatively Patient Satisfaction Score
| Post-Op Day 1 |
| Time to First opioid | Via chart review, time to first opioid within a 24 hour time period after spinal placement. | 24 hours |
| Total Opioid Dose | Via chart review, time to total opioids given within a 24 hour time period after spinal placement. | 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. | 20 minutes |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |