Bariatric Surgery Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain as assessed by the visual analog scale (VAS) | 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. | First 24 hours after surgery | |
Secondary | Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record) | the body temperature of the patient from the bladder | From the start surgery to the end of the surgery in minutes | |
Secondary | Temperature in the PACU | the temperature of the patient in PACU measured each 30 minutes in PACU | From the time the patient enters PACU to the time patient leaves the PACU in minutes | |
Secondary | Analgesic requirements in the Post Anesthesia Care Unit (PACU) | the amount, type and doses of drugs administered in the PACU to the patient | From the time the patient enters the PACU to the time patient leaves the PACU in minutes | |
Secondary | Volume of CO2 consumed during the procedure | the amount/volume of CO2 used during the procedure | from the time the CO2 machine is turned on to the time the CO2 machine is turned off in minutes | |
Secondary | Length of hospital stay | from admission to the hospital to discharge from the hospital in hours | the amount of hours the patient stays in the hospital (ie 24 hours) | |
Secondary | Duration of surgery | from the start of the first incision of surgery to the closing of the last incision of surgery in minutes | From start of the surgery to the end of the surgery in minutes | |
Secondary | Incision length | the length of the incisions on the patient abdomen | measurement in centimeters the patients incision lengths at the closing of the surgery | |
Secondary | Intra-operative and total hospital costs | the cost for the intra-operative services and total hospital hospital costs | from the admission to discharge of the patient in hours | |
Secondary | Total narcotic use intra-operatively (in morphine milliequivalents) | volume of narcotics used during the operation | volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents | |
Secondary | Postoperative Analgesia Requirement measured in morphine milliequivalents | the amount of analgesia used type, dose and amounts used post operatively | any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital |
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