Anesthesia, Spinal, Cesarean Section
Conditions
Keywords
Cesarean Section, Spinal Anesthesia, Intrathecal adjuncts, Dexmedetomidine, Epinephrine
Brief 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. 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.
Interventions
DRUGDexmedetomidine
5 mcg of dexmedetomidine
DRUGEpinephrine
200 mcg of epinephrine
DRUGStandardized Spinal Mixture
Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required for sensory recovery | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Bromage Score 1 | 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 |
| Blood Pressure | 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. |
| Phenylephrine Infusion Rate | 2 to 30 minutes | the phenylephrine infusion rate from 2 to 30 minutes after spinal placement |
| Total Phenylephrine Infusion | during surgery which can go up to 150 minutes | the total phenylephrine infusion given during surgery. |
| Number of Phenylephrine Boluses | during surgery which can go up to 150 minutes | Number of Phenylephrine Boluses given during the operation |
| Number of Ephedrine Boluses | during surgery which can go up to 150 minutes | Number of Ephedrine Boluses given during the operation |
| Number of Nausea episodes | 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. |
| Number of Vomiting episodes | 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. |
| Number of Shivering episodes | 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. |
| Number of Pruritus episodes | 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. |
| Pain Score at Skin Incision | 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). |
| Pain Score at Uterine Incision | 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). |
| Pain Score at Uterine Exteriorization | 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). |
| Pain Score at Uterine Closure | 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). |
| Pain Score at Gutter Cleaning | 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). |
| Pain Score at Procedure Finish | 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). |
| Additional IV Medication | 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). |
| Number of participants who require Conversion to General Anesthesia | 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. |
| Heart Rate | 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. |
| Oxygen Saturation | 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. |
| Apgar Scores | 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. |
| Number of NICU admission | Day 1 | Number of babies that require Neonatal Intensive Care Unit (NICU) admission from the OR. |
| Patient Satisfaction Score | Post-Op Day 1 | 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 to First opioid | 24 hours | Via chart review, time to first opioid within a 24 hour time period after spinal placement. |
| Total Opioid Dose | 24 hours | Via chart review, time to total opioids given within a 24 hour time period after spinal placement. |
| Time to sensory block | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Katz, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed