Analgesia Clinical Trial
Official title:
Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote
Verified date | May 2023 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | May 5, 2023 |
Est. primary completion date | January 20, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Ste-Justine Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Canada,
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* Note: There are 39 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 3 study feasability | The primary outcome will be to evaluate the phase 3 study feasability through recrutement rates and time needed to recrut a total of 52 patients | 3 months | |
Secondary | Opioids consumption | Total morphine equivalent consumed by the patient | 24 hours post-operatively | |
Secondary | Pruritus | Self-assessed validated numerical pruritus scale (NPS). Scale between 0 and 10, 10 being the worst symptoms the patient can imagine. | 2, 6, 12 and 24 hours after surgery | |
Secondary | Nausea | Absence or presence of nausea / vomiting at 2, 6, 12 and 24 hours after surgery | 2, 6, 12 and 24 hours after surgery | |
Secondary | Pain level | Self-assessed validated numerical pain scale (NPS).Scale between 0 and 10, 10 being the worst symptoms the patient can imagine. | 2, 6, 12 and 24 hours after surgery | |
Secondary | Quality of recovery and patient's satisfaction | Satisfaction according to the QoR15 questionnaire. Questionnaire containing 15 question to evaluate the quality of recovery in patients after a surgery. | 24 hours after surgery | |
Secondary | Nausea | Number of anti-nausea medication doses needed | 24 hours post-operatively |
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