Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The proposed study is a prospective, randomized, controlled, double-blind, single-center pilot study. 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.

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 and to demonstrate analgesia equivalent to the injection of opioids in intrathecal with lesser side effects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: Dexmedetomidine

Criteria

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