跳至主要内容
临床试验/CTRI/2017/11/010704
CTRI/2017/11/010704招募中不适用

Clinical Efficacy of Isobaric Ropivacaine 0.75%,4ml Alone and with Dexmedetomidine in Spinal Anaesthesia for Abdominal Hysterectomy: A Prospective Randomised Double Blind Study

未提供1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年1月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Clinical Efficacy of Isobaric Ropivacaine 0.75%,4ml Alone and with Dexmedetomidine in Spinal Anaesthesia for Abdominal Hysterectomy

研究概览

简要总结

Ropivacaine, first levo-isomer an amide local anaesthetic shares many physiochemical properties with bupivacaine but has shown a better safety profile over bupivacaine due to the reduced central nervous system and cardiac toxicity.(5,6) Recent clinical data have shown that ropivacaine is clinically effective and safe for regional anaesthetic techniques with good tolerability. Ropivacaine has been successfully used in spinal anaesthesia for caesarean section, urological surgery, and lower limb orthopedic surgery. However there is scarcity of data in which ropivacaine has been used in SAB for abdominal hysterectomy in which there is more extensive surgery, needing more relaxation than above mentioned surgeries. This prompted us to plan present study.When dexmedetomidine added to intrathecal ropivacaine better clinical profile was noted as compared to ropivacaine alone. However, no study comparing efficacy of ropivacaine 4ml of 0.75% versus ropivacaine 0.75% plus 5µg dexmetomedine in spinal anesthesia has been conducted to date.

 Therefore we are planning present study using 4 ml of 0.75% ropivacaine alone and with 5µg dexmedetomidine   in spinal anesthesia for abdominal hysterectomy, to study sensory and motor block characteristics, success rate, postoperative analgesia, haemodynamic profile, and complications.

Patients who will fulfill inclusion criteria will be enrolled in the study prior to enrolment written and informed consent will be taken. these patients will be randomly divided into two groups of 45 patients in each group using sealed envelope technique:

•   Group R: Patients will receive 4ml (30mg) of 0.75% Isobaric Ropivacaine hydrochloride.

•   Group RD: Patients will receive 4ml (30mg) of 0.75% Isobaric Ropivacaine with 5µg dexmedetomidine hydrochloride (0.05ml)

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • All ASA GRADE 1 AND 2 patients having age between 30 to 60 year weight 40 to 80 kg and height more than 140cm will be included.

排除标准

  • Patient refusal.
  • Contraindication to regional anaesthesia.
  • History of significant co-existing diseases like ischemic heart disease, hypertension, impaired renal functions, rheumatoid arthritis, severe liver disease and morbid obesity.
  • Atrio-ventricular block, incomplete or partial heart block.
  • Intake of α or β blockers.
  • Presence of anaemia, fused spine, coagulation disorder, diabetes, psychiatric illness, thyroid disease and malnourished patient,.Patient on any medication for systemic disease.
  • Allergy to amide local anaesthetics and dexmedetomidine.

结局指标

主要结局

Clinical Efficacy of Isobaric Ropivacaine 0.75%,4ml Alone and with Dexmedetomidine in Spinal Anaesthesia for Abdominal Hysterectomy

时间窗: six months period

次要结局

  • NA(NA)

研究者

发起方
未提供

研究点 (1)

Loading locations...

相似试验