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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03370562
Other study ID # 2017P000517
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2020
Est. completion date December 31, 2020

Study information

Verified date September 2021
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Administration of 10 mcg intravenous dexmedetomidine
Placebo
Administration of normal saline

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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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