Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Phase 3 study feasability
研究概览
简要总结
The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section.
The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.
详细描述
52 patients will be recruted for this study, and will be randomized in two equal groups.
All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics.
In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine.
In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment.
The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics.
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, Investigator)
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
- •Patient will receive an elective c-section under spinal anesthesia
- •Gestational age > 37 weeks
排除标准
- •ASA score ≥ 3
- •Allergy or contraindication to receiving opioids (morphine or fentanyl)
- •Allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, Naprosyn)
- •Allergy or contraindication to receiving acetaminophen
- •Height <152 cm or> 183 cm
- •Weight <50 or> 110 kg
- •Contraindication to spinal anesthesia
- •Conversion to general anesthesia
- •Combined spinal-epidural anesthesia
- •Inability to give informed consent, either secondary to a mental or physical disability or a significant language barrier (Inability to understand English or French)
- •Need for transfusion or other major complication
研究组 & 干预措施
Test group
Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with dexmedetomidine 3 mcg (0.75 mL) previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus.
干预措施: Dexmedetomidine 0.004 MG/ML [Precedex] (Drug)
Control group
Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with morphine 100 mcg, fentanyl 15 mcg and normal saline 0.25 ml previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus.
干预措施: Opioids (Drug)
结局指标
主要结局
Phase 3 study feasability
时间窗: 3 months
The primary outcome will be to evaluate the phase 3 study feasability through recrutement rates and time needed to recrut a total of 52 patients
次要结局
- Opioids consumption(24 hours post-operatively)
- Pruritus(2, 6, 12 and 24 hours after surgery)
- Nausea(24 hours post-operatively)
- Pain level(2, 6, 12 and 24 hours after surgery)
- Quality of recovery and patient's satisfaction(24 hours after surgery)
研究者
Christina Lamontagne
Anesthesioligist
St. Justine's Hospital