Bariatric Surgery
Conditions
Keywords
carbon dioxide, minimally invasive surgery
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.
Interventions
DEVICEWarm 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
DEVICEDry CO2
Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactErik B Wilson, MD,FACS
Backup ContactAngielyn Rivera
Outcome results
None listed