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临床试验/CTRI/2018/12/016739
CTRI/2018/12/016739已完成4 期

Comparison of efficacy of intrathecal nalbuphine vs fentanyl as adjuvant to subarachnoid block in caesarean section.

SHANMUGAVALLI E1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月25日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Onset time of sensry blockade.

研究概览

简要总结

This study is a randomized double blind controlled study to compare the efficacy and analgesic effect of intrathecal nalbuphine versus fentanyl as adjuvant to subarachnoid block in cesarean section

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • ASA Physical statusII Weight between 50 to 80 kilogram Height between 150 to 160 cm Cesarean section.

排除标准

  • ASA Physical status III,IV and V.patients receiving long term analgesic therapy,hypnotics or long term CNS depressants.Peripheral neuropathy.cogulopathy,infction at the site of injection.cardiac,hepatic or renal diseases.

结局指标

主要结局

Onset time of sensry blockade.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Onset time of motor blockade.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Highest level of sensory blockade.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Duration of motor blockade.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Ramsay sedation score in te post operative period.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Analgesic effect.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Two segment regression time.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Duration of effective analgesia.

时间窗: Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

次要结局

  • Intra operative parameters heart rate(Systolic blood pressure)

研究者

发起方
SHANMUGAVALLI E
申办方类型
Other [self]

研究点 (1)

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