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NCT04730609 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
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Active, not recruiting NCT05284409 - Comparative Study Between the Prophylactic Intravenous Administrations of Acetaminophen vs Dexamethasone vs Pethidine Regarding the Incidence of Shivering Induced by Single Shot Spinal Anesthesia in the Orthopedic Surgeries of the Lower Limbs Phase 4
Recruiting NCT03157648 - Relationship Between Core-peripheral Temperature Difference and Shivering Symptom in Patients in PACU N/A
Terminated NCT03497507 - Investigating the Effect of Acupressure on Shivering During a Cesarean Delivery in Women Who Were Previously Laboring With an Epidural N/A
Completed NCT03370562 - Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering N/A
Completed NCT05110469 - Comparison of MgSO4 Versus Meperidine for Prevention of Shivering During Spinal Anesthesia Phase 4
Not yet recruiting NCT03566628 - Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography N/A
Completed NCT02967601 - Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia N/A
Recruiting NCT05765162 - Safe Brain Initiative, Operationalizing Precision Anaesthesia
Recruiting NCT04870541 - Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering. Phase 4
Active, not recruiting NCT01669213 - Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension N/A

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