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临床试验/NCT07833800
NCT07833800已完成不适用

Effects of Operating Table Height on Subarachnoid Block Success by Anesthesia Residents in Faculty of Medicine University of Indonesia

Universitas Indonesia1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Procedure sucess

研究概览

简要总结

Operating table height influences operator comfort and performance during neuraxial anaesthesia, particularly when the patient is positioned sitting. This study aimed to analyse the effect of operating table height on the success rate and incidence of complications during spinal anesthesia, particularly done by trainees/residents.

详细描述

Patients who met the inclusion criteria and did not meet any exclusion criteria were randomised by computer software into two groups according to operating table height - set with puncture site at the level of the operator's umbilicus or the operator's xiphoid process - with group allocation concealed in opaque envelopes. Operators were enrolled by consecutive sampling, consisting of anaesthesiology residents who met the eligibility criteria and were present in the operating theatre during the study period. The outcomes assessed included subarachnoid block success, procedural duration from needle insertion to free flow of cerebrospinal fluid, the need for needle redirection, the need for needle reinsertion, operator comfort, operator posture analysis, and minor complications such as paresthesia or vascular puncture

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
None

入排标准

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

入选标准

  • adult patients aged 18-65 years scheduled for elective surgery under neuraxial subarachnoid block anaesthesia
  • classified as American Society of Anesthesiologists (ASA) physical status I-III
  • operator had performed fewer than 39 prior subarachnoid blocks

排除标准

  • body mass index >30 kg/m²
  • contraindications to subarachnoid block
  • patients' inability to be positioned sitting in accordance with the study protocol
  • unwillingness to participate
  • operator being unable to perform subarachnoid block according to protocol (injuries etc)
  • table height being unable to be adjusted to the target level

研究组 & 干预措施

Umbilicus

Experimental

Patients with table height set so that the puncture site is at operators' umbilicus level

干预措施: Table height (Behavioral)

Xyphoid process

Experimental

Patients with table height set so that puncture site is at the operators' xyphoid process level

干预措施: Table height (Behavioral)

结局指标

主要结局

Procedure sucess

时间窗: Measured during procedure and readily assessed in under 30 minutes

Determined as free flowing cerebrospinal fluid in spinal needle hub with total procedure time less than 10 minutes, redirection less than 5 minutes, and reinsertion less than 3 times, without occurrence of paresthesia and bloody tao

次要结局

  • Time to sucess(Measured during procedure and readily assessed in under 30 minutes)
  • Redirection(Measured during procedure and readily assessed in under 30 minutes)
  • Reinsertion(Measured during procedure and readily assessed in under 30 minutes)
  • Paresthesia(Measured during procedure and readily assessed in under 30 minutes)
  • Blood contamination(Measured during procedure and readily assessed in under 30 minutes)
  • Bloody tap(Measured during procedure and readily assessed in under 30 minutes)
  • Subjective comfort assessment(Measured directly by asking the operators after procedure)
  • Musculoskeletal complaints(Measured right after procedure)
  • Body postures score(Operators were documented during procedures and videos utilized for subsequent REBA scoring)

研究者

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

Rahendra Rahendra

dr. Rahendra, Sp.An-TI, Subsp.AR (K)

Universitas Indonesia

研究点 (1)

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