Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Pneumoperitoneum
• Interventions: Procedure: nitrous oxide use for pneumoperitoneum creation

• Registration Number: NCT01512511
• Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

Brief Summary

There is no general agreement about the ideal gas for pneumoperitoneum. CO2, now in common use, has not compared to N2O sufficiently to disclose which one has minimal "physiological" invasiveness characters. Assigned randomly to carbon dioxide or nitrous oxide group, the hemodynamic and respiratory parameters (heart rate, mean arterial blood pressure, end-tidal CO2, minute ventilation, and O2 saturation) before pneumoperitoneum and during it were recorded. Pain, as perceived by patients, is measured 2, 4 and 24 hours after the procedure by visual analogue scale. Vomiting and use of analgesics and antiemetics were recorded and compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-15
• Last Update Submitted: 2012-01-15
• Study First Posted: 2012-01-19
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• developed gallstones
• candidates for laparoscopic cholecystectomy
• written informed consent
• ASA Score = 1&2

Exclusion Criteria

• signs and complications of gallstones in admission include acute cholecystitis and suppurative cholangitis
• complete Inability to move
• severe physical or mental disorders leading to inability to communicate -Pregnancy and
• cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nitrous oxide	nitrous oxide use for pneumoperitoneum creation	use nitrous oxide for pneumoperitoneum creation
carbon dioxide	nitrous oxide use for pneumoperitoneum creation	use carbon dioxide for pneumoperitoneum creation

Primary Outcome Measures

Name	Time	Method
heart rate	At the start of laparoscopic surgery and Immediately after surgery.	number of heartbeats per minute measured in At the start of laparoscopic surgery and Immediately after surgery.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	At the start of laparoscopic surgery and Immediately after surgery.	average arterial pressure during a single cardiac cycle At the start of laparoscopic surgery and Immediately after surgery

Trial Locations

Locations (1)

Ahvaz jundishapur university of medical sciences; Razi Hospital; 🇮🇷 Ahvaz, Khuzestan, Iran, Islamic Republic of