NCT01667848

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Kepler University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cholecystolithiasis

Interventions

Type	Name	Description
DEVICE	Optitherm® device activated	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.
DEVICE	Optitherm® device inactivated	The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2012-08-17
• Last updated: 2023-10-05
• Results posted: 2014-04-30

Locations

1 site across 1 country: Austria