Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehdi Asgari, Ahvaz Jundishapur University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01512511
First received: January 3, 2012
Last updated: January 15, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Pneumoperitoneum
Procedure: nitrous oxide use for pneumoperitoneum creation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Ahvaz Jundishapur University of Medical Sciences:

Primary Outcome Measures:
  • heart rate [ Time Frame: At the start of laparoscopic surgery and Immediately after surgery. ] [ Designated as safety issue: Yes ]
    number of heartbeats per minute measured in At the start of laparoscopic surgery and Immediately after surgery.


Secondary Outcome Measures:
  • Mean arterial pressure [ Time Frame: At the start of laparoscopic surgery and Immediately after surgery. ] [ Designated as safety issue: Yes ]
    average arterial pressure during a single cardiac cycle At the start of laparoscopic surgery and Immediately after surgery


Enrollment: 64
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nitrous oxide
use nitrous oxide for pneumoperitoneum creation
Procedure: nitrous oxide use for pneumoperitoneum creation
use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy
Placebo Comparator: carbon dioxide
use carbon dioxide for pneumoperitoneum creation
Procedure: nitrous oxide use for pneumoperitoneum creation
use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512511

Locations
Iran, Islamic Republic of
Ahvaz jundishapur university of medical sciences; Razi Hospital
Ahvaz, Khuzestan, Iran, Islamic Republic of
Sponsors and Collaborators
Ahvaz Jundishapur University of Medical Sciences
Investigators
Principal Investigator: Mehdi Asgari, PhD Ahvaz Jundishapur University of Medical Sciences
  More Information

No publications provided

Responsible Party: Mehdi Asgari, Principal Investigator, Ahvaz Jundishapur University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01512511     History of Changes
Other Study ID Numbers: u-89140
Study First Received: January 3, 2012
Last Updated: January 15, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Ahvaz Jundishapur University of Medical Sciences:
laparoscopic cholecystectomy
pneumoperitoneum
nitrous oxide
carbon dioxide

Additional relevant MeSH terms:
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases
Nitrous Oxide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 09, 2014