Comparison of the Analgesic Efficacy of Two Adjuvants to Hyperbaric Bupivacaine During Spinal Anaesthesia for Caesarean Section.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The first requirement for analgesic
研究概览
简要总结
: Pain modulation is very important after operation, particularly for women who undergo caesarean section. A pain-free postoperative period is essential following a caesarean section so new mothers may care for and bond with their neonates. The consequences of the improper pain management which raise the healthcare costs and prolong the recovery process. Intrathecal adjuvants are often administered during this procedure to provide significant analgesia, but they may also have bothersome side effects. Intrathecal midazolam and magnesium sulfate produces effective postoperative analgesia with no significant side effects.
Objectives: This prospective, randomized, double-blind study was designed to compare the analgesic efficacy and safety of intrathecal midazolam vs. Magnesium sulfate vs plain bupivacaine as an adjunct to bupivacaine in pregnancy patients scheduled for elective caesarean section.
详细描述
The patients were randomly allocated using a computer-generated randomization list to one of three groups that contained 50 parturients each via www.randomization.com.
Group C (control group): 10 mg hyperbaric bupivacaine 0.5% (2 ml) + 100γ morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 1 ml physiological saline.
Group Mg (magnesium sulfate group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 100 mg MgSO4 (1 ml).
Group MDZ (midazolam group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ Sufentanil (0.5ml) + 2mg Midazolam (0.4 + 0.6cc physiological saline (1 ml)).
The parturients as well as the anesthetist who evaluated the protocol did not know the nature of the adjuvant injected in spinal anesthesia. The presented syringe contained one of the two adjuvants or the physiological serum in the same volume and of the same appearance. It was prepared by an anesthesist who was not included in the analysis of the study and was presented anonymously to the anesthetist in charge of the patient. A postoperative monitoring (PO) was performed during the first 24 hours in the intensive care unit by the anesthesist who did not know the nature of the injected adjuvant. All patients were kept nil per os for six hours prior to surgery.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a mono fetal pregnancy, term> 35 week, planned caesarean section under spinal anesthesia, six-hour fasting, and the American Society of Anesthesiologists (ASA) physical status I or II.
排除标准
- •contraindication for intrathecal injection, known allergies to midazolam, other benzodiazepines, magnesium sulfate, caesarean section in extreme urgency, preeclamptic parturient, foetal death in utero, premature delivery (<32SA), anomaly of the placentation, any significant cardiovascular or hepatorenal diseases, a history of seizures or convulsive neurological disease, an altered coagulation profile. Exclusion criteria: failure of spinal anesthesia, conversion into general anesthesia, anesthetic or surgical perioperative incident requiring resuscitation, traumatic puncture, occurrence of serious complication of spinal anesthesia, loss of blindness or randomization of patients.
研究组 & 干预措施
Group C
Control group
干预措施: Saline Solution (Drug)
Group Mg
Magnesium sulfate group
干预措施: Magnesium Sulfate (Drug)
Group MDZ
Midazolam group
干预措施: Midazolam 5 MG/ML Injection (Drug)
结局指标
主要结局
The first requirement for analgesic
时间窗: 24 hours postoperative
Postoperatively, the patients were observed for the duration of analgesia using the Visual Analog Scale for Pain (VAS Pain), from 0 - 10 (with 0 being no pain and 10 being the most severe pain imaginable) at H2, H4, H6, H10, H12, H24 at rest and coughing or mobilization until supplementary analgesia was required. The duration of effective analgesia was defined as the time interval between administration of the IT drug to the time of first analgesic request or a VAS ≥ 4. Rescue analgesics were given in the form of a paracetamol injection (1g IV) as well as nefopam (20 mg IV) injection once the VAS was recorded as 4 or more.
次要结局
- Hypotension(24 hours post operative)
- Bradycardia(24 hours post operative)
- The sensory blocks(24 hours postoperative)
- The motor block(24 hours postoperative)
- Sedation Score(24 hours post operative)
- Maternal satisfaction(24 hours post operative)
研究者
Fethi Jebali
Medical doctor, clinical professor of Anesthesiology and intensive care medecine
Centre de Maternité de Monastir