Skip to main content
OpenTrials
Completed

NCT Number: NCT01667848

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholecystolithiasis Biliary Tract Diseases Cholelithiasis Digestive System Diseases Gallbladder Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Surgical Department, Academic Teaching Hospital, AKH Linz

Linz, Upper Austria, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of cholecystolithiasis

Exclusion criteria

  • Clinical diagnosis of cholecystolithiasis with cholecystitis

Treatment and study plan

Optitherm® device activated

Device

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.

Other names: Optitherm® device (Storz, Tuttlingen, Germany)

Optitherm® device inactivated

Device

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

Other names: Optitherm® device (Storz, Tuttlingen, Germany)

Primary outcomes

  1. Pain (Rated With a Visual Analog Scale for Pain)

    Time frame: operation day

    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)

  2. Pain (Rated With a Visual Analog Scale for Pain)

    Time frame: first postoperative day

    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)

Secondary outcomes

  1. Core Temperature

    Time frame: one day postoperativly

  2. Core Temperature

    Time frame: during operation

    core temperature during laparoscopic cholecystectomy using a rectal probe

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 17, 2012
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.