Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy
Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedJanuary 19, 2012
January 1, 2012
4 months
January 3, 2012
January 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Mean arterial pressure
At the start of laparoscopic surgery and Immediately after surgery.
Study Arms (2)
nitrous oxide
EXPERIMENTALuse nitrous oxide for pneumoperitoneum creation
carbon dioxide
PLACEBO COMPARATORuse carbon dioxide for pneumoperitoneum creation
Interventions
use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy
Eligibility Criteria
You may qualify if:
- developed gallstones
- candidates for laparoscopic cholecystectomy
- written informed consent
- ASA Score = 1\&2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahvaz jundishapur university of medical sciences; Razi Hospital
Ahvāz, Khuzestan, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehdi Asgari, PhD
Ahvaz Jundishapur University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 19, 2012
Study Start
November 1, 2010
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
January 19, 2012
Record last verified: 2012-01