Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Shivering Clinical Trial

Official title:

Dexmedetomidine for Treatment of Shivering During Scheduled Elective Cesarean Delivery: Determining the Optimal Dose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730609
• Other study ID #: 20-004712
• Status: Recruiting
• Phase: Phase 4
• Start date: September 21, 2021
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the optimum dose of Dexmedetomidine to stop shivering in 90% of patients who experience shivering during scheduled elective cesarean deliveries.

Description:

Potential subjects will consist of parturients who present for scheduled elective cesarean deliveries. Patients will be recruited and consented for the study pre-operatively and if they display Grade 3 or 4 shivering at the time of delivery then they will be enrolled in the study. Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect - cessation of shivering within 5 minutes of medication administration. An anesthesia physician not involved in patient care or assessment will prepare the dexmedetomidine for intravenous use. Anesthesia will be initiated with spinal anesthesia with our institution's typical dosing of 1.6 mL 0.75% bupivacaine with dextrose, 15 mcg fentanyl, and 150 mcg morphine.

Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan. Members of the anesthesia team caring for women in the study will be educated on the grading scales.

• Grade 0: no shivering;

• Grade 1: one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity; Grade 2: visible muscle activity confined to one muscle group;

• Grade 3: visible muscle activity in more than one muscle group;

• Grade 4: gross muscle activity involving the whole body

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women presenting for planned cesarean delivery.

• American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.

• Singleton gestation in the 3rd trimester (28-42 weeks gestation).

• Spinal anesthesia technique Women presenting for planned cesarean delivery.

• American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.

• Singleton gestation in the 3rd trimester (28-42 weeks gestation).

• Spinal anesthesia technique.

Exclusion Criteria:

• Any contraindication to spinal anesthesia technique.

• Allergy or intolerance to dexmedetomidine or clonidine.

• Oral temperature < 36° Celsius prior to procedure.

• Unable to give personal consent.

• PPROM or concern for infection (e.g., chorioamnionitis).

• Conversion to General Anesthesia prior to randomization.

• Sedative medications (e.g., fentanyl, midazolam, ketamine, nitrous oxide) administered prior to randomization.

Related Conditions & MeSH terms

• Dose Finding Study
• Shivering

Intervention

Drug:
• Dexmedetomidine
Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan	Cessation of shivering	5 minutes after administration of the drug
Secondary	Maternal Heart Rate	Determination of the effect of varying doses of dexmedetomidine on maternal heart rate.	During intraoperative course
Secondary	Doses of dexmedetomidine	Determination of the effect of varying doses of dexmedetomidine on maternal sedation.	During intraoperative course

External Links

•   Mayo Clinic Clinical Trials