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

The University of Texas System (UT)

Status: Enrolling

Conditions: Bariatric Surgery

Treatments: Device: Dry CO2; Device: Warm humidified CO2

Study type: Interventional

Funder types: Other

Identifiers

NCT05838300

HSC-MS-22-0444

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Warm humidified CO2

Experimental group

Treatment:

Device: Warm humidified CO2

Dry CO2

Active Comparator group

Treatment:

Device: Dry CO2