PneumoperitoneumNCT01512511
Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy
A study testing nitrous oxide use for pneumoperitoneum creation in people with Pneumoperitoneum, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Pneumoperitoneum
- What is being tested?
- nitrous oxide use for pneumoperitoneum creation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIran
- Study dates
- Nov 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- developed gallstones
- candidates for laparoscopic cholecystectomy
- written informed consent
- ASA Score = 1\&2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Ahvaz jundishapur university of medical sciences; Razi Hospital
Ahvāz, Khuzestan
About this study
Official title: Prospective Randomized Trial 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.
- Conditions
- Pneumoperitoneum
- Being tested
- nitrous oxide use for pneumoperitoneum creation
- Keywords
- laparoscopic cholecystectomy, pneumoperitoneum, nitrous oxide, carbon dioxide
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrous oxide use for pneumoperitoneum creationProcedure or surgery
use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| nitrous oxide | Experimental | use nitrous oxide for pneumoperitoneum creation Receives: Procedure: nitrous oxide use for pneumoperitoneum creation |
| carbon dioxide | Placebo comparator | use carbon dioxide for pneumoperitoneum creation Receives: Procedure: nitrous oxide use for pneumoperitoneum creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
number of heartbeats per minute measured in At the start of laparoscopic surgery and Immediately after surgery.
Measured: At the start of laparoscopic surgery and Immediately after surgery.
Secondary outcomes (1)
Mean arterial pressure
average arterial pressure during a single cardiac cycle At the start of laparoscopic surgery and Immediately after surgery
Measured: At the start of laparoscopic surgery and Immediately after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahvaz Jundishapur University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Asgari, Ahvaz Jundishapur University of Medical Sciences
- Investigators
- Mehdi Asgari, PhD, Principal investigator, Ahvaz Jundishapur University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512511
- Sponsor's protocol ID
- u-89140
- Status last verified
- Jan 2012
- First submitted
- 3 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01512511
- Acronym / sponsor ID
- u-89140
- Conditions
- Pneumoperitoneum
- Keywords
- laparoscopic cholecystectomy, pneumoperitoneum, nitrous oxide, carbon dioxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ahvaz Jundishapur University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nitrous oxide | Experimental | Procedure: nitrous oxide use for pneumoperitoneum creationuse nitrous oxide for pneumoperitoneum creation |
| carbon dioxide | Placebo comparator | Procedure: nitrous oxide use for pneumoperitoneum creationuse carbon dioxide for pneumoperitoneum creation |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- developed gallstones
- candidates for laparoscopic cholecystectomy
- written informed consent
- ASA Score = 1\&2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitrous oxide use for pneumoperitoneum creationuse nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy | Procedure or surgery | carbon dioxide, nitrous oxide |
Primary outcome
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.
1 secondary outcome
Mean arterial pressure
Time frame: At the start of laparoscopic surgery and Immediately after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
Related trials for Pneumoperitoneum
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Not yet recruitingObservational study
Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery
Vnotes, Respiratory Mechanics
RecruitingObservational study
VC-AF vs FCV in Obese Patients Undergoing Laparoscopic Surgery
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The Turbine-based CO2 Insufflator Pediatric Feasibility Study
Laparoscopy, Pneumoperitoneum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi Asgari, PhD principal investigator
Ahvaz Jundishapur University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitrous oxide use for pneumoperitoneum creation in people with Pneumoperitoneum, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate (time frame: At the start of laparoscopic surgery and Immediately after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.