Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

Pneumoperitoneum Clinical Trial

Official title:

Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512511
• Other study ID #: u-89140
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: January 15, 2012
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2012
• Source: Ahvaz Jundishapur University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pneumoperitoneum

Intervention

Procedure:
• nitrous oxide use for pneumoperitoneum creation
use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ahvaz jundishapur university of medical sciences; Razi Hospital	Ahvaz	Khuzestan

Sponsors (1)

Lead Sponsor	Collaborator
Ahvaz Jundishapur University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	number of heartbeats per minute measured in At the start of laparoscopic surgery and Immediately after surgery.	At the start of laparoscopic surgery and Immediately after surgery.	Yes
Secondary	Mean arterial pressure	average arterial pressure during a single cardiac cycle At the start of laparoscopic surgery and Immediately after surgery	At the start of laparoscopic surgery and Immediately after surgery.	Yes