Clinical trial

Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote

Name

2022-3543

Description

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.

Trial arms

Trial start

2022-03-15

Estimated PCD

2023-01-20

Trial end

2023-05-05

Status

Completed

Phase

Early phase I

Treatment

Dexmedetomidine 0.004 MG/ML [Precedex]

Injection of 3 mcg of dexmedetomidine and 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.

Arms:

Test group

Opioids

Injection of 100 mcg of morphine, 15 mcg of fentanyl and 0.25 ml of normal salin (sterile) with 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.

Arms:

Control group

Size

Primary endpoint

Phase 3 study feasability

3 months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot study for a phase 3 study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

Updated at

2023-05-09

1 organization

2 products

7 indications

Organization

St. Justine's Hospital

Product

Dexmedetomidine

Indication

Analgesic

Indication