Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Overview

About this study

The purpose of this study is to determine the optimum dose of Dexmedetoidine to stop shivering in 90% of patients who experience shivering during cesarean delivery. We will be using an up-down sequential allocation method with biased-coin design to determine the ED90 of dexmedetomidine for effectively treating shivering during CD.

Perioperative shivering is a commonly observed intraoperative problem during cesarean delivery (CD). The median incidence of shivering in women undergoing CD or having labor epidural analgesia has been estimated to be over 50%. Shivering can create a number of problems including: increased physiologic stress, interference with patient monitors (e.g., blood pressure recording), and decreased patient satisfaction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Hans Sviggum, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Hans Sviggum, M.D.

Closed for enrollment

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