Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale.
研究概览
简要总结
The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is nowadays the common practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR)
- •Signed informed consent
排除标准
- •When subarachnoid block is contraindicated
- •Patient's denial in performing subarachnoid anesthesia
- •Failure of subarachnoid block (L1 dermatome in 30 minutes after intrathecal drug administration)
- •Mental illness or drug abuse
- •Estimated time of operation >90 minutes
研究组 & 干预措施
Group I
0.4 mgkg-1 of pethidine hydrochloride
干预措施: Pethidine hydrochloride (Drug)
Group II
2ml of ropivacaine (0.75%) with 15 mcg of fentanyl
干预措施: Ropivacaine HCl Inj 7.5 MG/ML (Drug)
Group II
2ml of ropivacaine (0.75%) with 15 mcg of fentanyl
干预措施: Fentanyl (Drug)
结局指标
主要结局
Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale.
时间窗: 30 minutes after the intrathecal administration of the drug
The level of motor block will be assessed by the modified Bromage scale.
Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the time of motor block establisment.
时间窗: 30 minutes after the intrathecal administration of the drug
Time of motor block establishment (Grade 2 in modified Bromage scale) will be recorded as well as the time of withdrawal. Failure of spinal block is considered when there is no block at the level of first lumbar vertebra 30 minutes after the intrathecal administration of the drugs and in these cases the patients are excluded from the study.
Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test.
时间窗: 30 minutes after the intrathecal administration of the drug
Low dose of pethidine hydrochloride will be administered for subarachnoid anesthesia in patients subjected to urologic operations.The level of sensory block after subarachnoid anesthesia will be assessed by the pinprick test.
次要结局
- Percentage of postsurgical catheter-related bladder discomfort(Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively)
- Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.(In the first 24 hours postoperatively)
- Length of stay in postanesthesia care unit(Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first.)
- Adverse events(All adverse events observed intraoperatively and in the first 24 hours postoperatively)
- Assessment of haemodynamic status of patients intraoperatively(During the operation)
研究者
Georgia Micha
Anesthesiologist,MD, MSc, PhD
Saint Savvas Anticancer Hospital