Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.

Detailed Description
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Patients undergoing warmed, humidified carbon dioxide (CO2) insufflation for laparoscopic cholecystectomy will have less postoperative pain than patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation. The study design is a double-blind, prospective, randomized study comparing patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation vs those receiving warmed, humidified CO2. Main variables included postoperative pain (rated with a visual analog scales) and analgesic requirements.

Official Title
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Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial

Conditions
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Cholecystolithiasis

Intervention / Treatment
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* Device: Optitherm® device activated
* Device: Optitherm® device inactivated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of cholecystolithiasis Exclusion Criteria: Clinical diagnosis of cholecystolithiasis with cholecystitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group B: Insufflation with warm gas<br>Insufflation with warmed, humidified carbon dioxide insufflation during laparoscopic cholecystectomy using the optitherm® device attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B. | Device: Optitherm® device activated<br>* The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.<br>* Other names: Optitherm® device (Storz, Tuttlingen, Germany);|
| Experimental: group A: Insufflation with cold gas<br>group A: Insufflation with cold gas during laparoscopic cholecystectomy, the use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A | Device: Optitherm® device inactivated<br>* The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.<br>* Other names: Optitherm® device (Storz, Tuttlingen, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Rated With a Visual Analog Scale for Pain) | postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day. The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain) | operation day | 
| Pain (Rated With a Visual Analog Scale for Pain) | postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day. The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain) | first postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core Temperature |  | one day postoperativly | 
| Core Temperature | core temperature during laparoscopic cholecystectomy using a rectal probe | during operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain