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

  • STATUS
    Recruiting
  • End date
    Jul 29, 2024
  • participants needed
    52
  • sponsor
    St. Justine's Hospital
Updated on 29 May 2022

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.

Description

52 patients will be recruted for this study, and will be randomized in two equal groups.

All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics.

In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine.

In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment.

The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics.

The patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her QoR15 questionnaire.

This will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects.

Details
Condition Analgesia, Analgesics, Opioid, Anesthesia, Obstetrical, Anesthesia, Spinal, Analgesics, Non-Narcotic, Dexmedetomidine, Analgesia, Obstetrical
Treatment opioids, Dexmedetomidine 0.004 MG/ML [Precedex]
Clinical Study IdentifierNCT05099055
SponsorSt. Justine's Hospital
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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
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