Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia

NCT07855536 | Not Yet Recruiting Phase 4

• 1 other identifier: Nasal Dex for Shivering in CS
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Shivering; Hypothermia; Cesarean Section; Spinal Anaesthesia

Keywords

Intranasal dexmedetomidine; Meperidine; Post-spinal shivering; Spinal anesthesia; Obstetric anesthesia; Thermoregulation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Intraoperative Shivering

  Participants will be assessed for the occurrence of intraoperative shivering using a 5-point scale: Grade 0 = no shivering; Grade 1 = piloerection, peripheral vasoconstriction, or cyanosis; Grade 2 = visible muscle activity confined to one muscle group; Grade 3 = visible muscle activity involving more than one muscle group; Grade 4 = gross muscle activity involving the whole body (scores range from 0 to 4, where 0 indicates no shivering and 4 indicates severe whole-body shivering). Shivering is defined as the occurrence of Grade 1 or higher at any time during the procedure.

  Through completion of surgery, up to 2 hours

Study Arms (3)

Group D: Intranasal Dexmedetomidine

EXPERIMENTAL

Participants receive intranasal dexmedetomidine 1 mcg/kg diluted in 2 mL normal saline administered 30 minutes before induction of spinal anesthesia in the pre-anesthesia room, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (double-dummy placebo) (n = 33).

Drug: Dexmedetomidine; Drug: Normal Saline 0.9%

Group M: Intravenous Meperidine

ACTIVE COMPARATOR

Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia (double-dummy placebo), along with an intravenous bolus of meperidine 0.5 mg/kg diluted to 10 mL normal saline immediately before spinal injection (n = 33).

Drug: Meperidine; Drug: Normal Saline 0.9%

Group C: Placebo Control

PLACEBO COMPARATOR

Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (n = 33).

Drug: Normal Saline 0.9%

Interventions

Dexmedetomidine DRUG

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.

Group D: Intranasal Dexmedetomidine

Meperidine DRUG

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.

Group M: Intravenous Meperidine

Normal Saline 0.9% DRUG

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).

Group C: Placebo Control; Group D: Intranasal Dexmedetomidine; Group M: Intravenous Meperidine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18 to 40 years.
• American Society of Anesthesiologists (ASA) physical status II.
• Term singleton pregnancy.
• Scheduled for elective cesarean section under spinal anesthesia.

You may not qualify if:

• Refusal to participate.
• Contraindications to spinal anesthesia.
• Nasal pathology preventing intranasal drug administration.
• Known allergy or hypersensitivity to any study medication (dexmedetomidine, meperidine, or bupivacaine).
• Significant cardiac disease.
• Renal or hepatic impairment.
• Preeclampsia, eclampsia, or HELLP syndrome.
• Cesarean section requiring general anesthesia.
• Body mass index (BMI) \> 40 kg/m².

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hypothermia

Interventions

Dexmedetomidine; Meperidine; Saline Solution

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09