Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pneumoperitoneum

Intervention / Treatment
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* Procedure: nitrous oxide use for pneumoperitoneum creation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nitrous oxide<br>use nitrous oxide for pneumoperitoneum creation | Procedure: nitrous oxide use for pneumoperitoneum creation<br>* use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy<br>|
| Placebo Comparator: carbon dioxide<br>use carbon dioxide for pneumoperitoneum creation | Procedure: nitrous oxide use for pneumoperitoneum creation<br>* use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic cholecystectomy, pneumoperitoneum, nitrous oxide, carbon dioxide