Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

NCT04730609 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20-004712
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shivering; Dose Finding Study

Keywords

Shivering; Cesarean Delivery; Dexmedetomidine; Dosing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maternal Heart Rate

  During intraoperative course

• Doses of dexmedetomidine

  During intraoperative course

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hans Sviggum, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans P Sviggum, MD

CONTACT

507-293-1169; sviggum.hans@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 29, 2021
• Study Start: September 21, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)