Intravenous Dexamethasone for Prolonging the Sensory Block Duration of Spinal Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Duration of sensory block
研究概览
简要总结
The goal of this clinical trial is to learn if intravenous dexamethasone can help prolong the effect of spinal anesthesia in adults having elective pelvic, urologic, or proctologic surgery. The study also looks at whether dexamethasone improves pain control after surgery and whether it causes any side effects.
The main questions it aims to answer are:
Does intravenous dexamethasone increase how long the spinal anesthesia lasts?
Does it reduce the need for pain medications after surgery?
Does it cause more or fewer side effects compared to a placebo?
In this study:
Participants were randomly assigned to receive either 8 mg of intravenous dexamethasone or a placebo (salt water).
All participants received standard spinal anesthesia with bupivacaine and sufentanil.
Researchers measured how long the spinal anesthesia lasted and when the first pain medication was needed after surgery.
Participants were monitored for side effects such as low blood pressure, nausea, vomiting, and slow heart rate.
Surgeon satisfaction with anesthesia quality was also recorded.
Participants did not receive any additional procedures beyond routine care. The study found that dexamethasone helped prolong the spinal anesthesia and delayed the need for pain relief, without increasing side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patient, anesthesia provider, surgeon, and outcome assessor were all blinded to group allocation. The syringes were prepared by a resident not involved in the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 80 years
- •ASA physical status I or II
- •Scheduled for elective pelvic surgery under spinal anesthesia (urologic, inguinal, or proctologic procedures)
- •Provided informed consent
排除标准
- •Known allergy to dexamethasone or local anaesthetics
- •Contraindications to spinal anesthesia
- •Neurological diseases
- •Chronic use of corticosteroids or immunosuppressants
- •BMI > 40 kg/m²
- •Refusal to participate
研究组 & 干预措施
Placebo Group
Participants in this arm received 2 mL of isotonic saline intravenously 5 minutes before spinal anesthesia. The spinal anesthesia was performed identically to the intervention group (12.5 mg of hyperbaric bupivacaine + 2.5 µg sufentanil). This arm served as the control group for evaluating the effects of dexamethasone.
干预措施: Placebo (Drug)
Intravenous Dexamethasone Group
Participants in this arm received 8 mg of intravenous dexamethasone (2 mL) 5 minutes before spinal anesthesia. The spinal anesthesia was performed with 12.5 mg of 0.5% hyperbaric bupivacaine combined with 2.5 µg of sufentanil. The purpose was to evaluate whether intravenous dexamethasone prolongs the duration of sensory and motor block and improves postoperative analgesia.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Duration of sensory block
时间窗: From the time of spinal injection until sensory regression to L1 dermatome (up to 4 hours postoperatively)
The duration of the sensory block was defined as the time from intrathecal injection of the local anesthetic until regression of sensory level to the L1 dermatome, as assessed by pinprick test every 15 minutes postoperatively. This endpoint was selected to evaluate the effect of intravenous dexamethasone on prolonging the duration of spinal anesthesia.
次要结局
- Duration of motor block(From the time of spinal injection until modified Bromage score = 3 (up to 4 hours postoperatively))
- Time to first analgesic request(From spinal injection until VAS score ≥ 3 and first analgesic request (up to 6 hours postoperatively))
- Incidence of adverse events(From spinal injection until the end of surgery)
- Surgeon satisfaction score(Immediately after the end of surgery)
研究者
Kamel ben Fadhel
Professor, Department of Anesthesiology and Intensive Care, Habib Thameur Hospital
Tunis University