Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03370562

Collaborator

(none)

100

Enrollment

Location

Arms

10.4

Actual Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Shivering Nausea and Vomiting, Postoperative	Drug: Dexmedetomidine Drug: Placebo	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Study medication provided in blinded syringe labeled with study number

Primary Purpose:

Treatment

Official Title:

Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

Actual Study Start Date :

Feb 18, 2020

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmedetomidine Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection	Drug: Dexmedetomidine Administration of 10 mcg intravenous dexmedetomidine Other Names: Precedex
Placebo Comparator: Placebo Patient will receive 5 ml of normal saline, administered by slow intravenous injection	Drug: Placebo Administration of normal saline Other Names: Saline

Arm

Intervention/Treatment

Active Comparator: Dexmedetomidine

Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection

Drug: Dexmedetomidine

Administration of 10 mcg intravenous dexmedetomidine

Other Names:

Precedex

Placebo Comparator: Placebo

Patient will receive 5 ml of normal saline, administered by slow intravenous injection

Drug: Placebo

Administration of normal saline

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Shivering measured by Visual analogue score [60 minutes]
Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Postoperative nausea and vomiting measured by Visual analogue score [60 minutes]
Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible

Secondary Outcome Measures

Pain measured by Visual analogue score [60 minutes]
Severity of incisional pain measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Pruritus measured by Visual analogue score [60 minutes]
Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Sedation measured by Visual analogue score [60 minutes]
Severity of postoperative sedation measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Dry mouth measured by Visual analogue score [60 minutes]
Severity of patient complaint of dry mouth measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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