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临床试验/NCT00308152
NCT00308152已完成2 期

Randomised, Controlled Trial of Intravenous Saline Pre-hydration in Patients Undergoing Outpatient Colonoscopy

The Canberra Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Time taken to resume normal activities

研究概览

简要总结

Colonoscopy and sedation are frequently accompanied by hypotension, which reduces the amount of sedation able to be employed. Blood pressure is restored by the infusion of intravenous normal saline. Prophylactic infusion of normal saline may enhance the colonoscopy completion rate, and patient comfort during colonoscopy and during the recovery from colonoscopy.

The investigators propose randomising consenting adult patients attending outpatient colonoscopy to one of two treatment arms:

(i) A control arm

(ii) A treatment arm, with pre-hydration with an infusion of 1.0 litre of normal saline immediately prior to colonoscopy.

Outcome measures include colonoscopy completion rates, hypotension during or after colonoscopy, and patient ratings of comfort and satisfaction.

详细描述

Outpatient colonoscopy is a generally well-tolerated elective procedure. Colonoscopy completion rate is governed in part by patient comfort, which is enhanced by adequate sedation. In addition, comfort following colonoscopy determines timely recovery from the procedure and return to usual activities.

Colonoscopy and sedation are frequently accompanied by hypotension (systolic blood pressure less than 100 mm Hg), which reduces the amount of sedation able to be employed. Where apparent, blood pressure is restored by infusion of intravenous normal saline. We have observed that hypotension is relatively common and may be present at or shortly after the commencement of the procedure, suggesting that many patients undergoing colonoscopy have reduced blood volume. Therefore, prophylactic infusion of normal saline may enhance colonoscopy completion rate, and patient comfort during colonoscopy and during recovery from colonoscopy.

We propose randomising consenting adult patients attending outpatient colonoscopy to one of two treatment arms:

(i) A control arm, with standard sedation and monitoring during colonoscopy, and infusion of normal saline if systolic BP ≤ 95 mmHg for more than 3 minutes (two observation periods) until completion of the procedure;

(ii) A treatment arm, with pre-hydration with an infusion of 1.0 litre of normal saline immediately prior to colonoscopy.

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
None

入排标准

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

入选标准

  • Aged 18 or older
  • Able to provide informed consent
  • Booked for outpatient colonoscopy, where appointment has been generated by Gastroenterology Unit bookings staff.

排除标准

  • Booked for anaesthetist-supervised colonoscopy because of previous sedation difficulties or significant co-morbidity (American Society of Anesthesiology Class III or IV)
  • Subjects requiring dialysis
  • Subjects receiving parenteral nutrition
  • Subjects with current congestive cardiac failure
  • Subjects with conditions preventing placement and accurate use of the automatic blood pressure cuff on the left arm, such as morbid obesity or lymphoedema

研究组 & 干预措施

Active

Active Comparator

Infusion of 1 liter normal saline before sedated colonoscopy

干预措施: Infusion of 1 litre of normal saline before colonoscopy (Drug)

结局指标

主要结局

Time taken to resume normal activities

The number of subjects with documented hypotension (systolic blood pressure [BP] ≤ 95 mmHg for 1 or more automatic BP measures taken at 3 minute intervals), during colonoscopy or the recovery period

Colonoscopy completion rates. Raw completion rates, with no allowance for failed bowel preparation or technical difficulties, will be used.

Comfort and satisfaction scores: discomfort during colonoscopy, discomfort after colonoscopy, satisfaction with sedation, overall satisfaction

Where relevant, adverse events such as post-procedure nausea, syncope, and prolonged recovery time, will be recorded in both arms of the study for comparison.

The number of subjects reaching criteria for discharge at 30 minutes after arrival in the recovery area

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

Dr Douglas Taupin

Senior Staff Specialist

The Canberra Hospital

研究点 (1)

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