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NCT Number: NCT05838300

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

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.

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Key information

Conditions

Bariatric Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warm humidified CO2

Device

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

Device

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

Primary outcomes

  1. Pain as assessed by the visual analog scale (VAS)

    Time frame: First 24 hours after surgery

    This will be measured as a binary outcome variable (pain will be determined as VAS >/= 4, and no pain will be VAS < 4). This will be determined on post-operative day 1 as an average of the two pain scores.

Secondary outcomes

  1. Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record)

    Time frame: From the start surgery to the end of the surgery in minutes

    the body temperature of the patient from the bladder

  2. Temperature in the PACU

    Time frame: From the time the patient enters PACU to the time patient leaves the PACU in minutes

    the temperature of the patient in PACU measured each 30 minutes in PACU

  3. Analgesic requirements in the Post Anesthesia Care Unit (PACU)

    Time frame: From the time the patient enters the PACU to the time patient leaves the PACU in minutes

    the amount, type and doses of drugs administered in the PACU to the patient

  4. Volume of CO2 consumed during the procedure

    Time frame: from the time the CO2 machine is turned on to the time the CO2 machine is turned off in minutes

    the amount/volume of CO2 used during the procedure

  5. Length of hospital stay

    Time frame: the amount of hours the patient stays in the hospital (ie 24 hours)

    from admission to the hospital to discharge from the hospital in hours

  6. Duration of surgery

    Time frame: From start of the surgery to the end of the surgery in minutes

    from the start of the first incision of surgery to the closing of the last incision of surgery in minutes

  7. Incision length

    Time frame: measurement in centimeters the patients incision lengths at the closing of the surgery

    the length of the incisions on the patient abdomen

  8. Intra-operative and total hospital costs

    Time frame: from the admission to discharge of the patient in hours

    the cost for the intra-operative services and total hospital hospital costs

  9. Total narcotic use intra-operatively (in morphine milliequivalents)

    Time frame: volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents

    volume of narcotics used during the operation

  10. Postoperative Analgesia Requirement measured in morphine milliequivalents

    Time frame: any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital

    the amount of analgesia used type, dose and amounts used post operatively

Study contacts

Contact information is provided by the study sponsor or research team.

Angielyn Rivera

CONTACT

[email protected]

713-416-1350

Erik B Wilson, MD,FACS

CONTACT

[email protected]

713-500-7277

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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