NCT05838300招募中不适用
Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery: A Randomized Controlled Study of Clinical Evaluation
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年5月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pain as assessed by the visual analog scale (VAS)
研究概览
简要总结
The purpose of this study is to To determine the effect of warm and humidified (WH) carbon dioxide (CO2) on post-operative pain/analgesia requirement in patients undergoing laparoscopic bariatric surgery.
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
- 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
- 否
入选标准
- •elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.
排除标准
- •emergency surgery, reoperation within 30 days
- •patients who are taking pain medications (narcotics) daily preoperatively for whatever reason
- •history of narcotics addiction
- •paraplegic and quadriplegic patients
- •dementia or altered mental status
- •patients on steroids
- •pregnant women
- •psychiatric patients
- •unable to give informed consent
研究组 & 干预措施
Warm humidified CO2
Experimental
干预措施: Warm humidified CO2 (Device)
Dry CO2
Active Comparator
干预措施: Dry CO2 (Device)
结局指标
主要结局
Pain as assessed by the visual analog scale (VAS)
时间窗: First 24 hours after surgery
This will be measured as a binary outcome variable (pain will be determined as VAS \>/= 4, and no pain will be VAS \< 4). This will be determined on post-operative day 1 as an average of the two pain scores.
次要结局
- Postoperative Analgesia Requirement measured in morphine milliequivalents(any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital)
- Incision length(measurement in centimeters the patients incision lengths at the closing of the surgery)
- Intra-operative and total hospital costs(from the admission to discharge of the patient in hours)
- Volume of CO2 consumed during the procedure(from the time the CO2 machine is turned on to the time the CO2 machine is turned off in minutes)
- Duration of surgery(From start of the surgery to the end of the surgery in minutes)
- Total narcotic use intra-operatively (in morphine milliequivalents)(volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents)
- Analgesic requirements in the Post Anesthesia Care Unit (PACU)(From the time the patient enters the PACU to the time patient leaves the PACU in minutes)
- Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record)(From the start surgery to the end of the surgery in minutes)
- Temperature in the PACU(From the time the patient enters PACU to the time patient leaves the PACU in minutes)
- Length of hospital stay(the amount of hours the patient stays in the hospital (ie 24 hours))
研究者
Erik B Wilson
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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