Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

Nausea and Vomiting, Postoperative Clinical Trial

Official title:

Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370562
• Other study ID #: 2017P000517
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Shivering
• Vomiting

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