CompletedPhase 3

Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study

Canada42 participantsStarted 2022-03-15

Plain-language summary

The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section. The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient will receive an elective c-section under spinal anesthesia * Gestational age \> 37 weeks Exclusion Criteria: * ASA score ≥ 3 * Allergy or contraindication to receiving opioids (morphine or fentanyl) * Allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, Naprosyn) * Allergy or contraindication to receiving acetaminophen * Height \<152 cm or\> 183 cm * Weight \<50 or\> 110 kg * Contraindication to spinal anesthesia * Conversion to general anesthesia * Combined spinal-epidural anesthesia * Inability to give informed consent, either secondary to a mental or physical disability or a significant language barrier (Inability to understand English or French) * Need for transfusion or other major complication

What they're measuring

Phase 3 study feasability

Timeframe: 3 months

Trial details

NCT IDNCT05099055

SponsorSt. Justine's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-20

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