Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation Vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery
- Conditions
- Bariatric Surgery
- Interventions
- Device: Dry CO2Device: Warm humidified CO2
- Registration Number
- NCT05838300
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
- elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dry CO2 Dry CO2 - Warm humidified CO2 Warm humidified CO2 -
- Primary Outcome Measures
Name Time Method Pain as assessed by the visual analog scale (VAS) 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 Outcome Measures
Name Time Method Postoperative Analgesia Requirement measured in morphine milliequivalents 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
Incision length measurement in centimeters the patients incision lengths at the closing of the surgery the length of the incisions on the patient abdomen
Intra-operative and total hospital costs from the admission to discharge of the patient in hours the cost for the intra-operative services and total hospital hospital costs
Volume of CO2 consumed during the procedure 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
Duration of surgery 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
Total narcotic use intra-operatively (in morphine milliequivalents) volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents volume of narcotics used during the operation
Analgesic requirements in the Post Anesthesia Care Unit (PACU) 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
Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record) From the start surgery to the end of the surgery in minutes the body temperature of the patient from the bladder
Temperature in the PACU 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
Length of hospital stay 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
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States