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

Kepler University Hospital148 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

148

Conditions

Cholecystolithiasis

Interventions

Optitherm® device activatedDEVICE

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.

Optitherm® device inactivatedDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of cholecystolithiasis Exclusion Criteria: * Clinical diagnosis of cholecystolithiasis with cholecystitis

Locations (1)

2nd Surgical Department, Academic Teaching Hospital, AKH Linz

Linz, Upper Austria, Austria

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: first postoperative day

Secondary Outcomes

Core Temperature

Time frame: one day postoperativly

Core Temperature

core temperature during laparoscopic cholecystectomy using a rectal probe

Time frame: during operation

Data from ClinicalTrials.gov

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