A COMPARATIVE STUDY OF INTRATHECAL MAGNESIUM SULPHATE VERSUS INTRATHECAL BUTORPHANOL AS ADJUVANT TO HYPERBARIC BUPIVACAINE IN ELECTIVE INFRAUMBILICAL GYNAECOLOGICAL SURGERY.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time of sensory and motor block,total duration of motor and sensory block,time for first rescue analgesia.
研究概览
简要总结
This study is a prospective, institution based, double blind, randomized comparative study. Place of study is PAC room and Gynecology OR at North Bengal Medical College.Period of study is one year.This study will compare the onset and duration of motor and sensory block due to addition of Magnesium Sulphate or Butorphanol as adjuvant added to Bupivacaine heavy in admitted patients undergoing gynecological surgeries under spinal anesthesia.In a Government Medical College in a hilly peripheral district in India like North Bengal Medical College, there is a lack of availability of commonly used opioids like Morphine , Meperidine and Fentanyl whereas agents like Magnesium Sulphate and Butorphanol are readily available for use as adjuvant in spinal anesthesia.However there is dearth of knowledge in comparison between these two agents when used as adjuvant in spinal anesthesia.Our study aims to find a direct comparative data between Butorphanol and Magnesium Sulphate as well as find out any complications as well as side effects of using these drugs as adjuvant in spinal anesthesia.Our hypothesis is that Butorphanol will be more effective as adjuvant in spinal anesthesia than Magnesium Sulphate in gynecological surgeries, both in terms of intraoperative as well as post operative pain relief.Calculated sample size is fifty patients with twenty five in each group.The time of sensory and motor block, duration of sensory and motor block, time for first rescue analgesia, timed measurement of vitals, perioperative VAS score and any postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patient posted for elective gynecological surgery Age 20 to 55yrs ASA 1 ,2 BMI 18.5 to 24.9.
排除标准
- •Refusal of patients to undergo this study History of hypersensitivity to any of the medications used in the study Active neurological, cardiac, respiratory, blood dyscrasias, renal disease, any contraindication of subarachnoid block Patients with dyselectrolytemias Surgery duration of more than 3 hrs.
- •Spinal deformity Pregnant patients.
结局指标
主要结局
Time of sensory and motor block,total duration of motor and sensory block,time for first rescue analgesia.
时间窗: 1 year
次要结局
- Quality of the block both sensory and motor (modified Bromage) and VAS scale for requirement of rescue analgesia.Monitoring of vital Spo2, SBP, DBP, PR(Comparison of any other notifiable adverse event like desaturation, severe hypotension, bradycardia etc. as well as any sedation, cardiac arrythmias, pruritus, hypersensitivity reaction.)
研究者
Poushali De
North Bengal Medical College and Hospital