Brief Title: Intranasal Dexmedetomidine for Prevention of Intrapartum Fever This study aims to evaluate the effect of intranasal dexmedetomidine (Dex) administered before neuraxial labor analgesia on the incidence of intrapartum fever in women undergoing vaginal delivery.
This prospective, randomized, double-blind, placebo-controlled trial will enroll 446 parturients scheduled for vaginal delivery with neuraxial labor analgesia at Chengdu Jinjiang Maternal and Child Health Hospital from 2026 to 2027. Participants will be randomly assigned in a 1:1 ratio to receive either intranasal Dex (50 μg) or an equal volume of normal saline before the initiation of labor analgesia.
Primary Outcome Measure:
Incidence of intrapartum fever (temperature ≥ 38.0℃) from initiation of labor analgesia to 2 hours postpartum
Secondary Outcome Measures:
Temperature-related outcomes: Incidence of fever at thresholds of ≥ 37.5℃ and ≥ 38.5℃; hourly temperature trends assessed by continuous wireless axillary monitoring Analgesic effect: NRS pain scores before labor analgesia and at 30 minutes, 1 hour, and 3 hours after analgesia Sedative effect: Ramsay Sedation Scale scores at the same time points Maternal safety: Incidence of bradycardia (heart rate \< 60 bpm), hypotension (systolic blood pressure \< 90 mmHg or \< 20% of baseline), nausea, vomiting, oversedation (Ramsay ≥ 4), and respiratory depression (SpO₂ \< 90%) Labor characteristics: Duration of first, second, and third stages of labor, total labor duration, and duration of labor analgesia Delivery outcomes: Mode of delivery (spontaneous vaginal delivery or cesarean section) and total consumption of local anesthetics Neonatal outcomes: Apgar scores at 1, 5, and 10 minutes, and NICU admission rate We hypothesize that intranasal Dex administered before labor analgesia will significantly reduce the incidence of intrapartum fever compared to placebo. This study is expected to provide a novel, non-invasive, and effective strategy for preventing epidural-related maternal fever, thereby improving maternal safety and perinatal outcomes in women undergoing vaginal delivery.
ASA physical status II or III
Age ≥ 18 years
Singleton pregnancy, cephalic presentation
No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia
Maternal temperature ≥ 37.3°C before labor analgesia
Allergy to α2-adrenergic receptor agonists
Severe pregnancy complications or systemic diseases
Use of analgesics, nonsteroidal anti-inflammatory drugs, or other medications that may affect body temperature within one week prior to enrollment
Parallel
Dexmedetomidine
DrugA single intranasal dose of dexmedetomidine 50 μg (25 μg per nostril) administered before combined spinal-epidural labor analgesia. Labor analgesia is maintained with ropivacaine and sufentanil via patient-controlled epidural analgesia pump.
Placebo
DrugIntranasal normal saline (one spray per nostril, total two sprays) administered as a single dose before initiation of Combined Spinal-Epidural labor analgesia. Identical in appearance, color, odor, and packaging to the dexmedetomidine nasal spray to maintain blinding.
Incidence of Labor Analgesia-Related Intrapartum Fever (LRIF)
Proportion of participants with maternal temperature ≥ 38.0°C measured from initiation of labor analgesia to 2 hours postpartum. Temperature is continuously monitored using a wireless axillary sensor.
Incidence of fever at different thresholds
Proportion of participants with maternal temperature ≥ 37.5°C and ≥ 38.5°C during the same period.
Hourly temperature trends
Maternal temperature recorded every hour from initiation of labor analgesia to 2 hours postpartum.
Analgesic effect (NRS pain scores)
Numeric Rating Scale (NRS) pain scores, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain. Assessed before labor analgesia (T0), and at 30 minutes (T1), 1 hour (T2), and 3 hours (T3) after analgesia.
Sedative effect (Ramsay Sedation Scale)
Ramsay Sedation Scale scores, ranging from 1 (anxious, agitated, or restless) to 6 (no response to light glabellar tap or loud auditory stimulus), with higher scores indicating deeper sedation. Assessed at the same time points as pain scores.
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