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临床试验/NCT07168135
NCT07168135进行中(未招募)不适用

Effect of Discontinuing Propofol Anesthesia After Cecal Intubation on Patient's Psychomotor Recovery Following Colonoscopy: A Prospective Two-Arm Parallel Randomized Double-Blind Interventional Controlled Trial

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月19日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Time to psychomotor recovery after the completion of the colonoscopy

研究概览

简要总结

This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.

详细描述

Colonoscopy is usually conducted after inducing depression in the patient's level of consciousness through sedation, ranging from minimal anxiolysis to general anesthesia, to establish relief from potential anxiety, discomfort, and pain during the procedure; in addition to diminishing the patient's memory of the event and minimizing the risk of adverse events related to agitation. It is traditionally done under endoscopist-directed conscious sedation via the administration of a benzodiazepine and a narcotic. However, anesthesia-assisted sedation has significantly risen for the last decade using almost exclusively propofol continuous intravenous drip, with propofol being a non-analgesic sedating agent marked by its rapid distribution and elimination and stronger sedating effect than the standard regimen, leading to faster induction and recovery from sedation and higher physician and patient satisfaction rates. Several anesthesia techniques were also introduced to ease the visceral pain associated with colonoscopy, such as intravenous lidocaine infusion, low-dose intravenous ketamine, and inhalation of an anesthetic mixture of oxygen with nitrous oxide.

Nevertheless, procedural sedation can induce mild cognitive decline after seemingly full recovery. Padmanabhan and colleagues report a significant decrease in visual attention and psychomotor function from baseline after sedation for colonoscopy. It is recommended by the guidelines for conscious sedation and monitoring during gastrointestinal endoscopy (ASGE, 2003) and the Institute Review of Endoscopic Sedation (AGA, 2008) that patients should be accompanied home by a responsible individual after endoscopic sedation, in addition to be instructed to avoid driving, make legally binding decisions, or operate heavy or potentially harmful machinery. The investigators have recently shown that an important proportion of patients experience periods of general anesthesia and/or a deep hypnotic state during endoscopy.

Prolonged systemic anesthesia is noted to increase the risk for serious complications in colonoscopy patients, either hemodynamically or psychomotorly. Additionally, Wernli and colleagues showed that the overall risk of complications after colonoscopy within 30 days increases when individuals receive anesthesia services, namely, the increased risk of perforation, abdominal pain, and stroke. Thus, minimizing the time systemic anesthesia is administered to the patient as possible during the procedure will likely reduce its potential side effects.

The withdrawal time following cecal intubation is quite controversial and operator-dependent. However, it is recommended to be between 6 and 9 minutes. Thus, withholding anesthetic agents during this phase might be beneficial. It would reduce the patient's exposure to anesthesia without causing any significant under-sedation until the near end of the procedure. At the same time, this intervention may accelerate the patient's post-procedure psychomotor recovery by terminating systemic sedation at an earlier checkpoint. Moreover, Adenoma detection rate (ADR), which refers to the rate of detecting colonic adenomas, is typically assessed during the withdrawal of the scope after cecal intubation. It is well known that this rate is influenced by the withdrawal time, meaning the duration the colonoscopist spends withdrawing the scope from the patient. Early discontinuation of anesthesia could limit the time available for the colonoscopist to detect adenomas during withdrawal, making it a significant outcome to evaluate after each colonoscopy.

This study explores whether discontinuing the continuous intravenous infusion of propofol directly following cecal intubation would shorten the patient's recovery time without affecting his comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.

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, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 80 years.
  • Scheduled ambulatory elective screening or surveillance colonoscopy under MAC.

排除标准

  • Medical contraindication to anesthesia (i.e., respiratory/cardiac/neurologic compromise, known allergy or adverse reaction to propofol, midazolam, lidocaine, or opiates, …)
  • History of ischemic or hemorrhagic cerebrovascular accident.
  • Baseline cognitive dysfunction (impaired memory, attention deficit, language disorders, …) - in other words, any dysfunction that prevents the subject from understanding the study protocol and/or completing the requested tests and assessments (e.g., playing the minigames, …)
  • Use of more than one psychoactive drug.
  • History of partial colectomy.
  • Unable to give consent.

研究组 & 干预措施

Propofol withdrawal arm

Experimental

This group will undergo withholding of the propofol sedation upon intubating the cecum during the colonoscopy.

干预措施: propofol (drug) (Drug)

结局指标

主要结局

Time to psychomotor recovery after the completion of the colonoscopy

时间窗: From enrollment until 24 hours after finishing the colonoscopy

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

Ala'a Sharara, MD

Professor of Gastroenterology

American University of Beirut Medical Center

研究点 (1)

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