Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
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Purpose
This study was developed to test the hypothesis that the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: nitrous oxide Drug: nitrogen |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study |
- To determine if the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery. [ Time Frame: 270 days post surrgery ] [ Designated as safety issue: No ]
| Enrollment: | 408 |
| Study Start Date: | November 1998 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: group 1
Colorectal surgery with 65% nitrous oxide administration
|
Drug: nitrous oxide
65% nitrous oxide administered during surgery
|
|
Active Comparator: group 2
Colorectal surgery with nitrogen administration
|
Drug: nitrogen
Nitrogen administration during surgery
|
Detailed Description:
We conducted a 4- to 8-year follow-up of 204 patients with colorectal cancer who were randomly assigned to 65% nitrous oxide (n=97) or nitrogen (n=107), balanced with isoflurane and remifentanil. The primary outcome was the time to cancer recurrence. Our primary analysis was a multivariable Cox-proportional-hazards regression model that included relevant baseline variables. In addition to treatment group, the model considered patient age, tumor grade, dissemination, adjacent organ invasion, vessel invasion, and the number of nodes involved. The study had 80% power to detect a 56% or greater reduction in recurrence rates (i.e., hazard ratio of 0.44 or less) at the 0.05 significance level.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects age 18-18
- ASA status 1-3
- Informed consent
Exclusion Criteria:
- Acute bowel obstruction
- Minor colon surgery
Contacts and Locations| Austria | |
| Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| Principal Investigator: | Edith Fleischmann, M.D. | Medical University of Vienna |
| Study Director: | Daniel I Sessler, M.D. | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Edith Fleischmann, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00781352 History of Changes |
| Other Study ID Numbers: | efno1008 |
| Study First Received: | October 27, 2008 |
| Last Updated: | October 28, 2008 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Outcomes Research Consortium:
|
nitrous oxide cancer recurrence colorectal surgery |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Recurrence Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Disease Attributes Pathologic Processes |
Nitrous Oxide Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 16, 2013