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Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Sponsor: Assiut University
Summary
Shivering is a common and distressing complication occurring in 40% to 60% of women undergoing cesarean section under spinal anesthesia. Beyond causing significant maternal discomfort, shivering markedly increases oxygen consumption and metabolic demand, elevates cardiopulmonary workload, and interferes with clinical monitoring. While intravenous meperidine remains a widely used pharmacological agent for shivering prophylaxis, it carries dose-dependent adverse effects such as nausea, vomiting, sedation, and potential neonatal depression. Intranasal dexmedetomidine provides an alternative needle-free method of administration that rapidly absorbs through the nasal mucosa and reduces shivering without suppressing respiratory drive. The primary purpose of this randomized controlled trial is to evaluate the efficacy of preoperative intranasal dexmedetomidine in reducing the incidence of intraoperative shivering compared with intravenous meperidine and placebo in women undergoing elective cesarean section under spinal anesthesia. A total of 99 parturients will be randomly allocated to one of three parallel groups (33 patients per group) using a double-dummy design: * Group D: Receives intranasal dexmedetomidine (1 mcg/kg) 30 minutes before spinal anesthesia, plus an intravenous saline placebo at spinal induction. * Group M: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous meperidine (0.5 mg/kg) at spinal induction. * Group C: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous saline placebo at spinal induction. Participants will be monitored throughout the surgical procedure to determine the occurrence of shivering, maternal hemodynamic parameters (heart rate, blood pressure, oxygen saturation), sedation levels using the Richmond Agitation-Sedation Scale (RASS), need for rescue anti-shivering medication, side effects, and neonatal outcomes (Apgar scores and birth weight).
Official title: Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia: Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2026-11
Completion Date
2027-12
Last Updated
2026-10-02
Healthy Volunteers
No
Interventions
Dexmedetomidine
Administered intranasally at a dose of 1 mcg/kg diluted in 2 mL normal saline 0.9% using a sterile dropper, instilled slowly into each nostril 30 minutes before induction of spinal anesthesia in the pre-anesthesia room.
Meperidine
Administered as an intravenous bolus at a dose of 0.5 mg/kg diluted to a total volume of 10 mL normal saline 0.9% immediately before the induction of spinal anesthesia.
Normal Saline 0.9%
Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction).