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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Erik B Wilson, MD, FACS
713-500-7277
Erik.B.Wilson@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Erik B Wilson, MD,FACS
713-500-7277
Erik.B.Wilson@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.