Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Completed; Phase 3

Conditions: Cesarean Section Complications

Treatments: Drug: Dexmedetomidine Injection; Drug: Meperidine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03115047

2017-7124

Details and patient eligibility

About

Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.

Full description

It is a double blinded randomized control trial.

Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan

Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes

Control group: meperidine 0.35 mg/kg IV in 2 minutes

Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug

Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia, maternal satisfaction and a cost-benefit analysis.

The hypothesis is that dexmedetomidine will act faster, will have a superior response rate with less adverse effects.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Term > 37 weeks
• American Society of Anesthesiologists Physical Status (ASA PS) I, II
• Weight < 115 kg
• Functional epidural in situ
• In labor requiring cesarean delivery
• Class III or IV shivering on the Crossley and Mahajan standardized shivering scale between five minutes after the baby's birth to the end of the cesarean section

Exclusion criteria

• Refusal of the patient and/or the anesthesiologist
• Misunderstanding of the protocol
• Known allergy or contraindication to one of the study drugs
• Emergency cesarean delivery
• American Society of Anesthesiologists Physical Status III, IV, V
• Severe heart, liver or kidney disease,
• Preeclampsia
• Patient taking monoamine oxydase inhibitors
• Sleep apnea
• General anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

dexmedetomidine

Experimental group

Description:

Unique dose of dexmedetomidine injection: * intravenous injection * 0.35 mcg/kg * in two minutes * if shivering 5 minutes after delivery

Treatment:

Drug: Dexmedetomidine Injection

meperidine

Active Comparator group

Description:

Unique dose of meperidine injection: * intravenous injection * 0.35 mg/kg * in two minutes * if shivering 5 minutes after delivery

Treatment:

Drug: Meperidine Injection