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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
5 mcg of dexmedetomidine
200 mcg of epinephrine
Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.
Mount Sinai Hospital
New York, New York, United States
RECRUITINGTime 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.
Time frame: 270 minutes
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
Time frame: 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.
Time frame: 30 minutes
Phenylephrine Infusion Rate
the phenylephrine infusion rate from 2 to 30 minutes after spinal placement
Time frame: 2 to 30 minutes
Total Phenylephrine Infusion
the total phenylephrine infusion given during surgery.
Time frame: during surgery which can go up to 150 minutes
Number of Phenylephrine Boluses
Number of Phenylephrine Boluses given during the operation
Time frame: during surgery which can go up to 150 minutes
Number of Ephedrine Boluses
Number of Ephedrine Boluses given during the operation
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 minute and 5 minutes
Number of NICU admission
Number of babies that require Neonatal Intensive Care Unit (NICU) admission from the OR.
Time frame: Day 1
Patient Satisfaction Score
Patient will be asked to score satisfaction postoperatively Patient Satisfaction Score 1. Completely dissatisfied 2. Partially dissatisfied 3. Neutral 4. Partially satisfied 5. Completely satisfied
Time frame: Post-Op Day 1
Time to First opioid
Via chart review, time to first opioid within a 24 hour time period after spinal placement.
Time frame: 24 hours
Total Opioid Dose
Via chart review, time to total opioids given within a 24 hour time period after spinal placement.
Time frame: 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.
Time frame: 20 minutes
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