Intranasal Dexmedetomidine and Labor Analgesia-Related Intrapartum Fever: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Incidence of Labor Analgesia-Related Intrapartum Fever (LRIF)
研究概览
简要总结
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.
详细描述
Background: Labor analgesia-related intrapartum fever (LRIF), defined as maternal temperature ≥ 38.0°C following labor analgesia, occurs in 15-25% of parturients and is associated with adverse maternal and neonatal outcomes. Dexmedetomidine (Dex) possesses anti-inflammatory properties, and intranasal administration offers rapid onset, high bioavailability, and non-invasiveness. However, its effect on LRIF has not been evaluated in high-quality prospective studies.
Study Design: This is a prospective, randomized, double-blind, placebo-controlled, single-center trial conducted at Chengdu Jinjiang Maternal and Child Health Hospital (2026-2027).
Intervention: Participants are randomized 1:1 to receive intranasal dexmedetomidine (50 μg, 25 μg per nostril) or intranasal normal saline (equal volume) immediately before labor analgesia. Labor analgesia follows a standardized combined spinal-epidural protocol with patient-controlled epidural analgesia.
Randomization and Blinding: A computer-generated random sequence with block size of 4 is used. Allocation is concealed in sequentially numbered, opaque, sealed envelopes. Double-blinding is implemented: participants, outcome assessors, data managers, and statisticians are blinded to group allocation. The attending anesthesiologist is unblinded but does not participate in any follow-up or outcome assessment.
Data Collection: Temperature is monitored continuously using wireless axillary sensors from analgesia initiation to 2 hours postpartum, ensuring capture of hourly temperature trends and fever events. Pain scores (NRS) and sedation levels (Ramsay Sedation Scale) are assessed at predefined time points: before analgesia, and at 30 min, 1 h, and 3 h after analgesia initiation. Data are extracted from electronic health records and case report forms, with double data entry and source data verification for primary outcome events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, outcome assessors, data managers, and statisticians are blinded to group allocation. The attending anesthesiologist is unblinded but does not participate in any follow-up or outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status II or III
- •Age ≥ 18 years
- •Singleton pregnancy, cephalic presentation
- •No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia
排除标准
- •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
- •Heart rate < 60 bpm or systolic blood pressure < 90 mmHg before labor analgesia
- •Severe rhinitis or nasal deformity
- •Premature rupture of membranes
结局指标
主要结局
Incidence of Labor Analgesia-Related Intrapartum Fever (LRIF)
时间窗: Up to 2 hours post-analgesia initiation
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.
次要结局
- NICU Admission Rate(During neonatal hospitalization)
- Incidence of fever at different thresholds(Up to 2 hours post-analgesia initiation)
- Hourly temperature trends(Hourly, up to 2 hours post-analgesia initiation)
- Analgesic effect (NRS pain scores)(Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation)
- Sedative effect (Ramsay Sedation Scale)(Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation)
- Labor characteristics(Throughout labor and delivery)
- Mode of delivery(At delivery)
- Total consumption of local anesthetics(From analgesia initiation to delivery)
- Incidence of Hypotension(Up to 2 hours post-analgesia initiation)
- Incidence of Bradycardia(Up to 2 hours post-analgesia initiation)
- Incidence of Nausea and Vomiting(Up to 2 hours post-analgesia initiation)
- Incidence of Oversedation(Up to 2 hours post-analgesia initiation)
- Incidence of Respiratory Depression(Up to 2 hours post-analgesia initiation)
- Neonatal Apgar Scores(1, 5, and 10 minutes post-delivery)
研究者
Fei Jia
Director of Anesthesiology Department
Chengdu Jinjiang Maternity and Child Health Hospital