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Completed

NCT Number: NCT06418308

Intrathecal Dexmedetomidine vs Epinephrine

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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Key information

Conditions

Cesarean Section Anesthesia, Spinal

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Hospital

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

5 mcg of dexmedetomidine

Epinephrine

Drug

200 mcg of epinephrine

Standardized Spinal Mixture

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to Bromage Score 1

    Time frame: 270 minutes

    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

  2. Blood Pressure

    Time frame: 30 minutes

    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.

  3. Phenylephrine Infusion Rate

    Time frame: 2 to 30 minutes

    the phenylephrine infusion rate from 2 to 30 minutes after spinal placement

  4. Total Phenylephrine Infusion

    Time frame: during surgery which can go up to 150 minutes

    the total phenylephrine infusion given during surgery.

  5. Number of Phenylephrine Boluses

    Time frame: during surgery which can go up to 150 minutes

    Number of Phenylephrine Boluses given during the operation

  6. Number of Ephedrine Boluses

    Time frame: during surgery which can go up to 150 minutes

    Number of Ephedrine Boluses given during the operation

  7. Number of Nausea episodes

    Time frame: 60 minutes

    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.

  8. Number of Vomiting episodes

    Time frame: 60 minutes

    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.

  9. Number of Shivering episodes

    Time frame: 60 minutes

    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.

  10. Number of Pruritus episodes

    Time frame: 60 minutes

    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.

  11. Pain Score at Skin Incision

    Time frame: within the surgery, which can go up to 150 minutes

    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).

  12. Pain Score at Uterine Incision

    Time frame: within the surgery, which can go up to 150 minutes

    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).

  13. Pain Score at Uterine Exteriorization

    Time frame: within the surgery, which can go up to 150 minutes

    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).

  14. Pain Score at Uterine Closure

    Time frame: within the surgery, which can go up to 150 minutes

    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).

  15. Pain Score at Gutter Cleaning

    Time frame: within the surgery, which can go up to 150 minutes

    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).

  16. Pain Score at Procedure Finish

    Time frame: at procedure finish, which can go up to 150 minutes

    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).

  17. Additional IV Medication

    Time frame: during surgery which can go up to 150 minutes

    Any additional IV medications that need to be given during the surgery will be recorded (e.g. IV fentanyl).

  18. Number of participants who require Conversion to General Anesthesia

    Time frame: during surgery which can go up to 150 minutes

    Number of participants who require Conversion to General Anesthesia. If converted to general anesthesia, enrollment in study will end.

  19. Heart Rate

    Time frame: total of 30 minutes from the time of spinal placement.

    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.

  20. Oxygen Saturation

    Time frame: total of 30 minutes from the time of spinal placement.

    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.

  21. Apgar Scores

    Time frame: 1 minute and 5 minutes

    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.

  22. Number of NICU admission

    Time frame: Day 1

    Number of babies that require Neonatal Intensive Care Unit (NICU) admission from the OR.

  23. Patient Satisfaction Score

    Time frame: Post-Op Day 1

    Patient will be asked to score satisfaction postoperatively Patient Satisfaction Score

    • Completely dissatisfied
    • Partially dissatisfied
    • Neutral
    • Partially satisfied
    • Completely satisfied

  24. Time to First opioid

    Time frame: 24 hours

    Via chart review, time to first opioid within a 24 hour time period after spinal placement.

  25. Total Opioid Dose

    Time frame: 24 hours

    Via chart review, time to total opioids given within a 24 hour time period after spinal placement.

  26. Time to sensory block

    Time frame: 20 minutes

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 17, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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