Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
While spinal anesthesia almost always creates a reasonably comfortable operative/birth experience, a significant proportion of women do experience significance "pressure" or "pulling" and some do have sensations described as painful during the operation. This has received increased interest in both the medical and lay press in recent years. The main medication in a spinal anesthetic is the local anesthetic, usually bupivacaine, but a variety of adjuvants can and are used to improve the analgesia and decrease sensation (or increase the time period of effectiveness) of the anesthetic. Opioids (usually fentanyl or sufentanil for intraoperative benefits and morphine for postoperative analgesia) are very commonly added to spinal anesthetics for cesarean delivery in the United States.
Somewhat less commonly, but increasingly, alpha-2 adrenergic agonists (clonidine or dexmedetomidine), which have sedative and analgesic properties (mostly analgesic when given into spinal fluid) are added in an attempt to improve the intraoperative experience and/or lengthen the time the block is effective. These adjuvants, although not approved specifically for this use in spinal anesthesia, have become more widely used in spinal anesthesia, including for cesarean delivery, and have been mentioned/recommended in recent statements by the American Society of Anesthesiologists for use when additional or improved analgesia may be needed or desired.
The quality of the studies of intrathecal dexmedetomidine as part of spinal anesthesia for cesarean delivery is quite poor. This study will investigate whether clonidine or dexmedetomidine, when added to a spinal anesthetic containing bupivacaine/fentanyl/morphine, will improve intraoperative analgesia/anesthesia, decrease unwanted sensation, and assess what the other effects will be (prolongation of sensory and motor block, effects on blood pressure, other side effects).
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Richard M Smiley, MD, PhD
- Numero di telefono: 914-584-9531
- Email: rms7@cumc.columbia.edu
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University Irving Medical Center/NewYork Presbyterian Hospital
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Investigatore principale:
- Ruth Landau, MD
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Contatto:
- Richard M Smiley, MD, PhD
- Numero di telefono: 914-584-9531
- Email: rms7@cumc.columbia.edu
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Contatto:
- Ruth Landau, MD
- Numero di telefono: 206-605-4527
- Email: rl262@cumc.columbia.edu
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Sub-investigatore:
- Richard M Smiley, MD, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Pregnant women undergoing cesarean delivery with spinal anesthesia
Exclusion Criteria:
- Significant cardiovascular, psychiatric or respiratory disease
- using opioids or with chronic pain syndrome
- Multiple gestation
- BMI >40 kg/m2
- Quaternary or greater cesarean
- < 37 weeks gestation
- Non-English or Spanish speaking
- planned vertical skin incision
- planned vertical (classical) uterine incision
- allergy to clonidine, dexmedetomidine or other study drug
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Clonidine
Participants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
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30 mcg Clonidine will be given by intrathecal administration
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Sperimentale: Dexmedetomidine
Participants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
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4 mcg Dexmedetomidine will be given by intrathecal administration
Altri nomi:
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Nessun intervento: Control
Participants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of intraoperative discomfort
Lasso di tempo: during cesarean surgery
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The primary outcome of this study is the incidence of self-reported intraoperative discomfort, defined as pain or uncomfortable pressure, tugging, pulling feeling during cesarean delivery. At specific timepoints during cesarean delivery surgery, the patient will be asked "Do you feel uncomfortable sensations (pain, pressure, pulling, tugging)?" If the answer is "yes, " she will be asked "Do you want medication to treat it?" The timepoints specified will be:
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during cesarean surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Obstetric Quality of Recovery (ObsQoR-10) Score
Lasso di tempo: 0-6, 6-12, 12-24, 24-48 hours after surgery
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Postoperative pain will be assessed by the self-reported Obstetric Quality of Recovery Score after surgery.
The full scale is 0 to 10, with 0 being no pain, and 10 being the worst pain imaginable.
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0-6, 6-12, 12-24, 24-48 hours after surgery
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Length of motor and sensory block
Lasso di tempo: 2-5 hours
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How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area
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2-5 hours
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Incidence of Hypotension
Lasso di tempo: first 20 minutes after spinal, or until delivery
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1. Decrease in baseline systolic blood pressure greater than 20%, or to less than 90 mm HG
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first 20 minutes after spinal, or until delivery
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Phenylephrine use
Lasso di tempo: 20 minutes
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Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).
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20 minutes
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PACU side-effects/events
Lasso di tempo: 2-3 hours postop
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Events in the post-anesthesia care unit:
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2-3 hours postop
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Blood pressure
Lasso di tempo: ~ 20 minutes from spinal injection
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Systolic and diastolic blood pressure every minute from spinal injection for 20 minutes or until delivery (whichever comes first)
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~ 20 minutes from spinal injection
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Additional vasopressor use
Lasso di tempo: From Spinal anesthesia to 20 minutes or delivery (whichever comes first)
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Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion
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From Spinal anesthesia to 20 minutes or delivery (whichever comes first)
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Numerical reading on PMD-200
Lasso di tempo: 1-2 hours (intraoperatve)
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Reading on the PMD (an FDA-approved device that uses a finger probe to detect "nociception," " a measure of sensation/discomfort/pain. The readngs will be recorded at the following timepoints:
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1-2 hours (intraoperatve)
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Opioid use postoperatively
Lasso di tempo: 48 hours
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Milligram morphine equivalents used over 48 hours postop
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48 hours
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Side effects
Lasso di tempo: 48 hours postop
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nausea/vomiting, itching
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48 hours postop
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UA and UV blood gases
Lasso di tempo: at delivery
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Umbilical artery and vein blood gases at birth
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at delivery
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Need for neonatal resuscitation
Lasso di tempo: birth to 2 hours
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need for care beyond routine neonatal care
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birth to 2 hours
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Heart rate (pulse)
Lasso di tempo: Spinal injection to 20 min later or delivery (~20 min)
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2. Heart rate every minute from spinal injection for 20 minutes or until delivery (whichever is first)
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Spinal injection to 20 min later or delivery (~20 min)
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ruth Landau, MD, Columbia University
Pubblicazioni e link utili
Pubblicazioni generali
- New York Times, Podcast, The Retrievals, Season 2, episodes 1-4.
- Orbach-Zinger S, Azem K, Bar M, Heesen P, Kozuch D, Furman D, Cohen R, Kashkush A, Izyumsky D, Fein S, Frenkel A, Shavialiou A, Binyamin Y. Intra-operative sensation during caesarean delivery under neuraxial anaesthesia: A prospective cohort study mapping sensory experiences. Eur J Anaesthesiol. 2026 Mar 1;43(3):217-225. doi: 10.1097/EJA.0000000000002317. Epub 2025 Nov 11.
- Takalo E, Karpala M, An X, Cobb B, Zhao S, Bari R, Hylton M, Grant S, Schoenherr J. Intrathecal dexmedetomidine for cesarean delivery and postoperative outcomes: a single-center retrospective cohort study (2019-2020). Int J Obstet Anesth. 2026 Feb;65:104819. doi: 10.1016/j.ijoa.2025.104819. Epub 2025 Nov 14.
- Fernandes HS, Bliacheriene F, Vago TM, Corregliano GT, Torres ML, Francisco RP, Ashmawi HA. Clonidine Effect on Pain After Cesarean Delivery: A Randomized Controlled Trial of Different Routes of Administration. Anesth Analg. 2018 Jul;127(1):165-170. doi: 10.1213/ANE.0000000000003319.
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Altri numeri di identificazione dello studio
- ACYY0438
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