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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warm humidified CO2 | Experimental |
| |
| Dry CO2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Temperature in the PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik B Wilson, MD,FACS | Contact | 713-500-7277 | Erik.B.Wilson@uth.tmc.edu | |
| Angielyn Rivera | Contact | 713-416-1350 | Angielyn.R.Rivera@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erik Wilson, MD, FACS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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|
| Dry CO2 | Device | Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator |
|
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 |
| 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 |
| 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 |
| 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) |
| 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 |
| Incision length | the length of the incisions on the patient abdomen | measurement in centimeters the patients incision lengths at the closing of the surgery |
| 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 |
| 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 |
| 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 |