Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04730609
Collaborator
(none)
40
1
1
16.4
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dexmedetomidine for Treatment of Shivering During Scheduled Elective Cesarean Delivery: Determining the Optimal Dose
Actual Study Start Date :
Sep 21, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan [5 minutes after administration of the drug]

    Cessation of shivering

Secondary Outcome Measures

  1. Maternal Heart Rate [During intraoperative course]

    Determination of the effect of varying doses of dexmedetomidine on maternal heart rate.

  2. Doses of dexmedetomidine [During intraoperative course]

    Determination of the effect of varying doses of dexmedetomidine on maternal sedation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Hans Sviggum, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Hans P. Sviggum, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04730609
Other Study ID Numbers:
  • 20-004712
First Posted:
Jan 29, 2021
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hans P. Sviggum, M.D., Principal Investigator, Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2021