Clinical trial NCT05838300: Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery
Keywords: carbon dioxide
minimally invasive surgery
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Pain as assessed by the visual analog scale (VAS)
timeFrame: First 24 hours after surgery
Secondary outcomes:
measure: Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record)
timeFrame: From the start surgery to the end of the surgery in minutes
measure: Temperature in the PACU
timeFrame: From the time the patient enters PACU to the time patient leaves the PACU in minutes
measure: Analgesic requirements in the Post Anesthesia Care Unit (PACU)
timeFrame: From the time the patient enters the PACU to the time patient leaves the PACU in minutes
measure: Volume of CO2 consumed during the procedure
timeFrame: from the time the CO2 machine is turned on to the time the CO2 machine is turned off in minutes
measure: Length of hospital stay
timeFrame: the amount of hours the patient stays in the hospital (ie 24 hours)
measure: Duration of surgery
timeFrame: From start of the surgery to the end of the surgery in minutes
measure: Incision length
timeFrame: measurement in centimeters the patients incision lengths at the closing of the surgery
measure: Intra-operative and total hospital costs
timeFrame: from the admission to discharge of the patient in hours
measure: Total narcotic use intra-operatively (in morphine milliequivalents)
timeFrame: volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents
measure: Postoperative Analgesia Requirement measured in morphine milliequivalents
timeFrame: any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Erik Wilson, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: