CTRI/2022/03/040896尚未招募不适用
Analgesic effect of intrathecal two different doses of nalbuphine 0.8mg versus 1.6 mg as an adjuvant to 0.75% isobaric ropivacaine for elective lower limb surgeries: a randomized double blind controlled interventional study
Sawai Man Singh medical college and atttached hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年3月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To access and compare the time duration for need of first rescue dose of analgesic among three groups
研究概览
简要总结
By studying and comparing the analgesic effect of above mentioned doses of intrathecal nalbuphine as an adjuvant to 0.75% isobaric ropivacaine along with control group in elective lower limb surgeries will help us to be more efficient in providing best anaesthesia possible to the patient and open up to more research projects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of either sex.
- •Age group between 18 to 60 years.
- •Weight of the patient between 40-70 kilograms.
- •Height of the patient ≥ 145cm.
- •Patients belonging to ASA class I and II.
- •Patients undergoing elective lower limb surgery.
排除标准
- •Patient’s refusal for spinal anaesthesia.
- •Uncooperative patients.
- •Patients not willing to participate in the study.
- •Patients with compromised airway or morbid obesity.
- •Patients with contraindications for spinal anesthesia.
- •History of convulsion, allergy to the drug used, bleeding disorder, severe neurological deficit.
- •Patients with history of hypertension, diabetes mallietus, respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
- •Pregnant patients.
- •Patient receiving phenothiazine, hypnotics or other central nervous system depressants.
- •â€¢Patients in which spinal anesthesia failed.
结局指标
主要结局
To access and compare the time duration for need of first rescue dose of analgesic among three groups
时间窗: At every 2 minutes for initial 10 minutes, 5 minutes for 10-30 minutes then every 10 minutes till surgery ends and then every 30 minutes for 6 hours after giving subarachnoid block.
次要结局
- 1.To find out the difference in mean onset time & duration of sensory & motor block between the three groups.(2.To assess & compare hemodynamic parameters (heart rate, mean blood pressure, systolic blood pressure & diastolic blood pressure), sedation score and post-operative visual analogue scale score.)
研究者
研究点 (1)
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