Dexmedetomidin för intraoperativ frossa vid planerad elektiv kejsarsnittsförlossning
Dexmedetomidin för behandling av frossa under planerad elektiv kejsarsnittsförlossning: bestämma den optimala dosen
The purpose of this study is to determine the optimum dose of Dexmedetomidine to stop shivering in 90% of patients who experience shivering during scheduled elective cesarean deliveries.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Potential subjects will consist of parturients who present for scheduled elective cesarean deliveries. Patients will be recruited and consented for the study pre-operatively and if they display Grade 3 or 4 shivering at the time of delivery then they will be enrolled in the study. Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect - cessation of shivering within 5 minutes of medication administration. An anesthesia physician not involved in patient care or assessment will prepare the dexmedetomidine for intravenous use. Anesthesia will be initiated with spinal anesthesia with our institution's typical dosing of 1.6 mL 0.75% bupivacaine with dextrose, 15 mcg fentanyl, and 150 mcg morphine.
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan. Members of the anesthesia team caring for women in the study will be educated on the grading scales.
- Grade 0: no shivering;
- Grade 1: one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity; Grade 2: visible muscle activity confined to one muscle group;
- Grade 3: visible muscle activity in more than one muscle group;
- Grade 4: gross muscle activity involving the whole body
Studietyp
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Women presenting for planned cesarean delivery.
- American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
- Singleton gestation in the 3rd trimester (28-42 weeks gestation).
- Spinal anesthesia technique Women presenting for planned cesarean delivery.
- American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
- Singleton gestation in the 3rd trimester (28-42 weeks gestation).
- Spinal anesthesia technique.
Exclusion Criteria:
- Any contraindication to spinal anesthesia technique.
- Allergy or intolerance to dexmedetomidine or clonidine.
- Oral temperature < 36° Celsius prior to procedure.
- Unable to give personal consent.
- PPROM or concern for infection (e.g., chorioamnionitis).
- Conversion to General Anesthesia prior to randomization.
- Sedative medications (e.g., fentanyl, midazolam, ketamine, nitrous oxide) administered prior to randomization.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Dexmedetomidine
IV administration of Dexmedetomidine, using an Up-Down method utilizing a biased coin design to determine that next patient's dose. Initial dose will be 10mcg. |
Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan
Tidsram: 5 minutes after administration of the drug
|
Cessation of shivering |
5 minutes after administration of the drug
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maternal Heart Rate
Tidsram: During intraoperative course
|
Determination of the effect of varying doses of dexmedetomidine on maternal heart rate. |
During intraoperative course
|
|
Doses of dexmedetomidine
Tidsram: During intraoperative course
|
Determination of the effect of varying doses of dexmedetomidine on maternal sedation. |
During intraoperative course
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Hans Sviggum, MD, Mayo Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20-004712
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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