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临床试验/NCT07466121
NCT07466121已完成不适用

Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery: A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年3月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Time to readiness for discharge

研究概览

简要总结

Most minor perianal surgeries are performed as day-case procedures requiring rapid recovery and effective symptom control. Saddle block anesthesia (SBA) provides reliable perineal anesthesia with minimal hemodynamic and motor effects, promoting faster recovery than general anesthesia. However, the duration of sitting after intrathecal injection influences anesthetic spread, and the optimal sitting time to balance adequate anesthesia with early discharge remains unclear.

详细描述

Spinal anesthesia will be administered in the sitting position at the L4-5 interspinous space using 7.5 mg of 0.5% hyperbaric bupivacaine.

Hemodynamic data (heart rate and blood pressure) will be recorded at baseline, then at 2 min interval after SBA until the end of surgery.

Postoperative pain will be assessed using the numeric rating scale at the post anesthesia care unit (PACU) and before discharge. If the numeric rating scale (NRS) > 3 or at any time if demanded by the patient, 15 mg of IV ketorolac will be given if persisted titrated doses of nalbuphine will be given In case of postoperative nausea and vomiting, 4 mg of IV ondansetron will be given.

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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (21-65 years), ASA I-III undergoing perianal surgery.

排除标准

  • Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, arrhythmias, tight valvular lesions)
  • Contraindication to neuraxial anesthesia such as coagulopathy and local infection
  • Pregnant or lactating women,
  • Allergy of any of the study drugs

研究组 & 干预措施

5-min group

Active Comparator

干预措施: 5-min sitting duration after SBA (Other)

8-min group

Active Comparator

干预措施: 8-min sitting duration after SBA (Other)

结局指标

主要结局

Time to readiness for discharge

时间窗: During the first 24 hour postoperatively

Patients will be considered ready for discharge when the modified Post Anaesthetic Discharge Scoring System (PADSS) \>9

次要结局

  • time to void(from SBA till 24 hour postoperatively)
  • time to ambulation(from SBA till 24 hour postoperatively)
  • quality of recovery(at the end of 24 hour after surgery)

研究者

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

Ahmed Hasanin

Professor

Cairo University

研究点 (1)

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