The Effect of Adding Ultra-low Dose of Naloxone to Fentanyl on the Incidence of Pruritis After Spinal Anesthesia for Cesarean Section: Prospective Randomized Double-blind Study ÏÑÇÓÉ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- The incidence of pruritis
研究概览
简要总结
This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:-
- Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
- Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone.
The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S.
Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.
详细描述
This prospective randomized double-blind study will be carried out on 80 female patients who will be presented for elective C.S in the Obstetric department in Tanta university hospitals.
Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia will be included in the study.
The patients will be randomly allocated into two groups by the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ugs naloxone.
Once the patient will be admitted to the operating theatre, all monitors will be applied with introduction of 18-gauge peripheral venous cannula and starting fluid preload in the form of lactated ringer solution 7 ml/kg over 30 minutes. While the patient in a sitting position and under complete aseptic precautions, patients will receive spinal block at lumbar 3-4 or 4-5 intervertebral space with an injection of the pre-prepared local anesthetic mixture according to the group of patient. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at a rate of 4 liters/minute will be applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- The patients will be blinded to their groups.
- An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions.
- The anesthetist who will perform the spinal anesthesia will be blinded to the local anesthetic mixtures he will inject intrathecally.
- An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in collection of the data of measurments.
入排标准
- 年龄范围
- 21 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia.
排除标准
- •Patients with pregnancy less than 36 weeks or more than 40 weeks
- •Patients with hypertension, pre-eclampsia, or eclampsia.
- •Patients with diabetes
- •Patients with cardiovascular disease and /or arrhythmia.
- •Patients with placenta previa, accreta, percreta.
- •Obese patients with BMI >36 Kg/m2
- •Patients with height less than 160 Cm
- •Multigravida
- •Polyhydramnious patients
研究组 & 干预措施
Group F
Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml).
干预措施: Fentanyl (Drug)
Group FN
Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml) plus 20 ugs naloxone.
干预措施: Fentanyl (Drug)
Group FN
Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ugs of fentanyl (0.5 ml) plus 20 ugs naloxone.
干预措施: Naloxone (Drug)
结局指标
主要结局
The incidence of pruritis
时间窗: The first 24 hours postoperatively
The percent of patients who will complain from pruritis in the first 24 hours after surgery
次要结局
- The onset of pruritis(through study completion, average 4 months)
- The duration of pruritis(through study completion, average 4 months)
- The Severity of pruritis(through study completion, average 4 months)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Clinical Professor
Tanta University