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临床试验/NCT07841184
NCT07841184招募中4 期

Comparison of Modified Saddle Block With Spinal Anesthesia Among Patients Undergoing Transurethral Resection of Prostate Cancer; A Randomized Control Trial at a Tertiary Care Hospital

Pakistan Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年8月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Maximum fall in Mean Arterial Pressure

研究概览

简要总结

After obtaining informed consent, eligible patients will be enrolled in the study. Standard monitoring will be applied in the operating room and baseline blood pressure and heart rate will be recorded. Participants will be randomly assigned to receive either spinal anesthesia or a modified saddle block using hyperbaric bupivacaine administered in the lower back. The position of the patient after injection will differ according to the assigned anesthetic technique. The level of numbness produced by the anesthesia will be assessed, and patients with inadequate anesthesia will be excluded. Blood pressure and heart rate will be monitored regularly during surgery. Any significant decrease in blood pressure will be treated with intravenous phenylephrine. Any need to change to general anesthesia during the procedure will also be recorded.

详细描述

After informed consent, patient fulfilling the inclusion criteria will be enrolled in the study. All patients will be brought into OR and standard ASA monitoring will be attached and baseline hemodynamics will be recorded. Patients will be randomly divided into two groups using computer generated random numbers. Group N patients will receive spinal anesthesia with 15mg of hyperbaric bupivacaine at L3 L4 level using 25G spinal needle while group S will receive saddle block with 15 mg of hyperbaric bupivacaine at L3 L4 level using 25 G spinal needle. Those receiving spinal anesthesia will be made to lie down immediately after intrathecal drug administration while those who received saddle block will be made to sit for five minutes and then will be made to lie down. Level of block will be assessed. Those having block less than T10 dermatome will be made excluded from the study. Intraoperatively hemodynamics will be monitored at 3 minutes interval. Any fall in blood pressure by more than 20% from baseline or fall in MAP to less than 65 mm of Hg will be noted and treated with Phenylephrine IV bolus of 50-100 Mcg. Intraoperatively any conversion to general anesthesia will also be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Age 40- 90 years
  • •Elective TURP surgery under Neuraxial Anesthesia
  • •ASA class I and II

排除标准

  • •Contraindication to Neuraxial anesthesia
  • •Allergic to study medications
  • •Lack of consent

研究组 & 干预措施

Group Saddle

Active Comparator

Patients in this group will receive Saddle block

干预措施: Saddle block (Drug)

Group Spinal anesthesia

Active Comparator

Patients in this group will receive Spinal anesthesia

干预措施: Spinal Anesthesia (bupivacaine) (Drug)

结局指标

主要结局

Maximum fall in Mean Arterial Pressure

时间窗: Peri-operative from From induction of anesthesia until completion of surgery

Maximum decrease in mean arterial pressure (MAP) from the pre-induction baseline value recorded during the intraoperative period, measured using automated oscillometric non-invasive blood pressure monitoring. MAP will be recorded at predefined intraoperative intervals, and the greatest fall from baseline will be reported in mmHg.

次要结局

  • Conversion rate to General Anesthesia(Peri-operative)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Department of Anesthesia

Principal Investigator

Pakistan Institute of Medical Sciences

研究点 (1)

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