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临床试验/NCT07156968
NCT07156968已完成不适用

Can Different Intrathecal Drugs Affect Day Case Anal Surgery Recovery Duration?

Ain Shams University1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2022年1月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
Sensory block resolution to S3 block

研究概览

简要总结

This study aims to compare effect of adding fentanyl or dexmetomidine on duration of motor and sensory block after spinal anesthesia with prilocaine during day case perianal surgery and whether it impact time to discharge home.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-70
  • height <155cm or >175cm
  • Day case perianal surgery

排除标准

  • Hypersensitivity to the study drugs
  • Refusal of patients.
  • Patients with contraindications for spinal anesthesia
  • previous voiding difficulty
  • patients taking anticholinergic medications.
  • emergency cases
  • Patients with contraindications for day case sitting.

研究组 & 干预措施

The bupivacaine-fentanyl group

Experimental

干预措施: Bupivacaine-fentanyl (Drug)

The prilocaine-fentanyl group

Experimental

干预措施: Bupivacaine-fentanyl (Drug)

The prilocaine-dexametomidine group

Experimental

干预措施: Bupivacaine-fentanyl (Drug)

结局指标

主要结局

Sensory block resolution to S3 block

时间窗: at 1 min intervals until the maximum block will be achieved and at 15 min intervals thereafter until the block resolved to S3 dermatome.

The sensory block will be measured at the midclavicular line with a pinprick test (via a 22 gauge hypodermic needle)

Home discharge

时间窗: Home discharge will be assessed as the time from the end of surgery until the patients reach a post-anesthesia discharge score

(modified Alderts score) ≥9, able to void spontaneously and the sensory block resolves to the S3 dermatome.

incidence of postoperative urinary retention (POUR)

时间窗: within 6 hours after surgery

The postoperative urinary retention (POUR) will be evaluated at hourly intervals in the PACU and ward; ultrasonic bladder scanning will be used for this purpose. If the bladder volume exceeds 500 mL and the patient has not voided spontaneously, urinary catheterization will be introduced.

次要结局

未报告次要终点

研究者

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

Nasser Sayed

Lecturer

Ain Shams University

研究点 (1)

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