Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Warm humidified CO2
  Participants will receive warm (37°C) and humidified (95%) CO2.The humidification and warming device to be used is AlwaysPneumo® AP 50/30 InsuflowPort® (Lexion Medical, FDA approved) which is a specialized port that delivers warmed (95° F) and humidified (95% relative humidity) CO2, the source of which is a standard CO2 tank or wall source
• Устройство Dry CO2
  Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator

Первичные конечные точки

• Pain as assessed by the visual analog scale (VAS) [Срок оценки: First 24 hours after surgery]

Вторичные конечные точки (10)

• Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record) [Срок оценки: From the start surgery to the end of the surgery in minutes]
• Temperature in the PACU [Срок оценки: From the time the patient enters PACU to the time patient leaves the PACU in minutes]
• Analgesic requirements in the Post Anesthesia Care Unit (PACU) [Срок оценки: From the time the patient enters the PACU to the time patient leaves the PACU in minutes]
• Volume of CO2 consumed during the procedure [Срок оценки: from the time the CO2 machine is turned on to the time the CO2 machine is turned off in minutes]
• Length of hospital stay [Срок оценки: the amount of hours the patient stays in the hospital (ie 24 hours)]
• Duration of surgery [Срок оценки: From start of the surgery to the end of the surgery in minutes]
• Incision length [Срок оценки: measurement in centimeters the patients incision lengths at the closing of the surgery]
• Intra-operative and total hospital costs [Срок оценки: from the admission to discharge of the patient in hours]
• Total narcotic use intra-operatively (in morphine milliequivalents) [Срок оценки: volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents]
• Postoperative Analgesia Requirement measured in morphine milliequivalents [Срок оценки: any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital]

Критерии участия

Критерии включения

• elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.

Критерии исключения

• 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
• minors
• unable to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT05838300 · HSC-MS-22-0444

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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