Ketamine as a Sedation Adjunct for Endoscopic Procedures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Provider satisfaction
研究概览
简要总结
We will be investigating the use of ketamine in sedation for endoscopic procedures, specifically outpatient endoscopy including esophagoduodenoscopy (EGD) and colonoscopy. Participants will be randomized to one of two arms including conventional moderate sedation with midazolam and fentanyl or the ketamine arm. They will then undergo the planned procedure. Physicians preforming the procedure will be surveyed following the procedure and patients will be surveyed twice, once after meeting criteria for discharge on day of the procedure and a second time 48 hours following the procedure.
详细描述
In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Gastroenterology Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting to the endoscopy lab for esophagogastroduodenoscopy (EGD) and/or colonoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either a ketamine loading dose and then subsequent doses IV ketamine and midazolam 1mg IV prior to administration of ketamine or standard fentanyl/midazolam moderate sedation during their procedure. Participants will then undergo the planned procedure. The primary outcome will be patient satisfaction, which will be measured using the validated "Patient Satisfaction with Sedation" instrument (PSSI). A number of secondary outcomes will include the following: (1) provider satisfaction (measured using and the "Clinician Satisfaction with Sedation" instrument (CSSI), (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to recovery (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (4) time to cecum (for colonoscopy) total doses of medications given (midazolam, fentanyl, and ketamine), (5) overall time of the procedure, (6) adverse events, (7) changes in vital signs, (8) and the need for additional medications, in particular reversal agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Patients age 18 to 65 years who present to the GI clinic for an EGD or colonoscopy
排除标准
- •Poor vital sign stability
- •Hypoxia: O2 < 92%,
- •Hypotension, hypertension, heart rate and respiratory rates greater than 20% above or below normal as dictated by normal ranges in SAMMC protocol
- •Any allergy to ketamine, fentanyl, or midazolam
- •Patient is pregnant or refuses pregnancy test, in women of child-bearing potential.*
- •American Society of Anesthesiologists (ASA) score>3
- •Presence of a history of psychosis, hallucinations, and/or a psychotic disorder
- •History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months
- •Active pulmonary infection or disease.
- •History of airway instability, tracheal surgery, or tracheal stenosis.
- •* Not applicable if patient is a female over 50 years old or has had a hysterectomy and/or oophorectomy
研究组 & 干预措施
Ketamine
Group will receive ketamine 0.5-1mg/kg for a loading dose then subsequent IV pushes of 10-20mg for maintenance. 1mg IV of midazolam will be administered prior to ketamine for anxiolysis and to help minimize emergence reaction.
干预措施: Ketamine (Drug)
Ketamine
Group will receive ketamine 0.5-1mg/kg for a loading dose then subsequent IV pushes of 10-20mg for maintenance. 1mg IV of midazolam will be administered prior to ketamine for anxiolysis and to help minimize emergence reaction.
干预措施: Midazolam injection (Drug)
Control
This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.
干预措施: Midazolam injection (Drug)
Control
This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Provider satisfaction
时间窗: Measured within 15 minutes post proceudre
Measured with CSSI score. This consists of a questionnaire administered to the provider following the procedure with questions detailing different aspects of the procedure. Answers will be summed and the scores are normalized to a scale of 0-100 (high scores denote higher satisfaction).
次要结局
- Sedation time(During the procedure)
- Overall procedure time(During the procedure)
- Patient Satisfaction(After patient reaches criteria for discharge as listed above, a survey will be preformed. It will also be preformed 48 hours post procedure with the patients being called. Two surveys will end patient participation in the study.)
- Time to cecum (for colonoscopy)(During the procedure)
- Adverse events(During the procedure)
- Need for additional medications, ie reversal agents(During the procedure)
- Total dose of medications given(During the procedure)
- Changes in vital signs(During the procedure)
研究者
Jerome Edelson
Physician
Brooke Army Medical Center