Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shivering; Dose Finding Study
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Mickelson Randa; Phone Number: 507-284-9697; Email: mickelson.randa@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; IV administration of Dexmedetomidine, using an Up-Down method utilizing a biased coin design to determine that next patient's dose. Initial dose will be 10mcg.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Heart Rate	Determination of the effect of varying doses of dexmedetomidine on maternal heart rate.	During intraoperative course
Doses of dexmedetomidine	Determination of the effect of varying doses of dexmedetomidine on maternal sedation.	During intraoperative course

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Hans Sviggum, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Cesarean Delivery; Shivering; Dosing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 20-004712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No