Recruiting

Lexion AP

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05838300

Conditions

Bariatric Surgery

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Warm humidified CO2

Dry CO2

Study Details

Brief 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.

Conditions

Bariatric Surgery

Study ID

NCT05838300

Start date

May 19, 2023

Status verified date

Jun, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Warm humidified CO2

active comparator: Dry CO2

Interventions

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

Dry CO2

Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Erik B Wilson, MD,FACS

713-500-7277Erik.B.Wilson@uth.tmc.edu

Angielyn Rivera

713-416-1350Angielyn.R.Rivera@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Erik B Wilson, MD, FACS

713-500-7277Erik.B.Wilson@uth.tmc.edu

Angielyn Rivera

713-416-1350Angielyn.R.Rivera@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 13, 2025

Last verified

Jun, 2025

Keywords

  • carbon dioxide
  • minimally invasive surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-06-13.