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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
54
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
Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGPain 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.
Time frame: First 24 hours after surgery
Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record)
the body temperature of the patient from the bladder
Time frame: From the start surgery to the end of the surgery in minutes
Temperature in the PACU
the temperature of the patient in PACU measured each 30 minutes in PACU
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: the amount of hours the patient stays in the hospital (ie 24 hours)
Duration of surgery
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from the start of the first incision of surgery to the closing of the last incision of surgery in minutes
Time frame: From start of the surgery to the end of the surgery in minutes
Incision length
the length of the incisions on the patient abdomen
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital