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Completed

NCT Number: NCT01512511

Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

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.

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahvaz jundishapur university of medical sciences; Razi Hospital

Ahvāz, Khuzestan, Iran

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

nitrous oxide use for pneumoperitoneum creation

Procedure

use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy

Primary outcomes

  1. heart rate

    Time frame: 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 outcomes

  1. Mean arterial pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ahvaz Jundishapur University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 19, 2012
Registry last updated
Jan 19, 2012

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.

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