Comparing warm humidified CO2 and dry CO2 for pain management in bariatric 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
This study is testing if using warm, humidified carbon dioxide during bariatric surgery can help reduce pain and the need for pain medication afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05838300 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of warm and humidified carbon dioxide (CO2) on postoperative pain and analgesia requirements in patients undergoing laparoscopic bariatric surgery. Participants will be randomly assigned to receive either warm humidified CO2 or dry CO2 during their procedure. The primary focus is to assess whether the use of warm humidified CO2 can lead to reduced pain levels and lower the need for pain medication post-surgery. The study will include elective bariatric primary or revision procedures and hiatal hernia repairs.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing elective primary or revision bariatric surgery or hiatal hernia repair.
Not a fit: Patients who are undergoing emergency surgery, have a history of narcotics addiction, or have conditions that impair their ability to consent or understand the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and the need for analgesics in bariatric surgery patients.
How similar studies have performed: While the use of warm humidified CO2 in surgical settings is promising, this specific approach in bariatric surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Erik Wilson, MD, FACS — The University of Texas Health Science Center, Houston
- Study coordinator: Erik B Wilson, MD,FACS
- Email: Erik.B.Wilson@uth.tmc.edu
- Phone: 713-500-7277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.