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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.
This study is a randomized, placebo controlled, double blind evaluation of the use of a single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean delivery. It is hypothesized that patients who receive dexmedetomidine (as compared to placebo) will have a reduced severity of postoperative shivering and nausea.
Study subjects will be have a scheduled cesarean section. They will receive written, informed consent obtained before surgery. After enrollment, patients will receive spinal anesthesia consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. All IV fluid will be warmed.
After delivery of the neonate, delivery of the placenta, and assurance of adequate uterine tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe consisting of either placebo saline, or 10 mcg of dexmedetomidine.
Study outcomes will be measured on an 11-point Likert scale assessing shivering, nausea, pain, pruritus, and sedation. Assessments will be performed on admission to the recovery room, and at 30 and 60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection |
|
| Placebo | Placebo Comparator | Patient will receive 5 ml of normal saline, administered by slow intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Administration of 10 mcg intravenous dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pruritus measured by Visual analogue score |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant females will be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Philip E Hess, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Study medication provided in blinded syringe labeled with study number
| Placebo | Drug | Administration of normal saline |
|
|
Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
| 60 minutes |
| 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 |
| 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 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |