Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery
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, Houston
54 participants
May 19, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.
Exclusion Criteria10
- 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
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Interventions
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
Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator
Locations(1)
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NCT05838300