Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01512511

Enrollment

Registered

2012-01-19

Start date

2010-11-30

Completion date

2011-04-30

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumoperitoneum

Keywords

laparoscopic cholecystectomy, pneumoperitoneum, nitrous oxide, carbon dioxide

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.

Interventions

PROCEDUREnitrous oxide use for pneumoperitoneum creation

use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
heart rate	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

Measure	Time frame	Description
Mean arterial pressure	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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026