Nausea and Vomiting, Postoperative Clinical Trial
Official title:
Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
Verified date | September 2021 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | March 20, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Elective cesarean delivery - = 18 years of age - Singleton pregnancy - Term delivery (37 weeks or greater gestation) - Spinal or combined spinal-epidural anesthesia is planned Exclusion Criteria: - Non-elective cesarean delivery - Receiving misoprostil or carboprost - Postpartum hemorrhage greater that 1000cc - Chronic opioid use - History of chronic nausea or itching in pregnancy - Receiving medications for nausea - Inability to provide written informed consent - Receiving of any of the following medications intraoperatively: misoprostil, carboprost, medications for nausea - Postpartum hemorrhage greater that 1000cc |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shivering measured by Visual analogue score | Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible | 60 minutes | |
Primary | Postoperative nausea and vomiting measured by Visual analogue score | Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible | 60 minutes | |
Secondary | Pain measured by Visual analogue score | Severity of incisional pain measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible | 60 minutes | |
Secondary | Pruritus measured by Visual analogue score | Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible | 60 minutes | |
Secondary | Sedation measured by Visual analogue score | Severity of postoperative sedation measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible | 60 minutes | |
Secondary | Dry mouth measured by Visual analogue score | Severity of patient complaint of dry mouth measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible | 60 minutes |
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