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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05838300
Other study ID # HSC-MS-22-0444
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2023
Est. completion date June 30, 2024

Study information

Verified date March 2024
Source The University of Texas Health Science Center, Houston
Contact Erik B Wilson, MD,FACS
Phone 713-500-7277
Email Erik.B.Wilson@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Warm 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
Dry CO2
Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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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