Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study

NCT ID: NCT00781352

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-11-30
• Study Completion Date: 2007-03-31

Brief Summary

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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

group 1

Colorectal surgery with 65% nitrous oxide administration

Group Type: ACTIVE_COMPARATOR

nitrous oxide

Intervention Type: DRUG

65% nitrous oxide administered during surgery

group 2

Colorectal surgery with nitrogen administration

Group Type: ACTIVE_COMPARATOR

nitrogen

Intervention Type: DRUG

Nitrogen administration during surgery

Interventions

nitrous oxide

65% nitrous oxide administered during surgery

Intervention Type: DRUG

nitrogen

Nitrogen administration during surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects age 18-18
• ASA status 1-3
• Informed consent

Exclusion Criteria

• Acute bowel obstruction
• Minor colon surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Vienna

Principal Investigators

Edith Fleischmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Daniel I Sessler, M.D.

Role: STUDY_DIRECTOR

The Cleveland Clinic

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

Fleischmann E, Marschalek C, Schlemitz K, Dalton JE, Gruenberger T, Herbst F, Kurz A, Sessler DI. Nitrous oxide may not increase the risk of cancer recurrence after colorectal surgery: a follow-up of a randomized controlled trial. BMC Anesthesiol. 2009 Feb 3;9:1. doi: 10.1186/1471-2253-9-1.

Reference Type: DERIVED

PMID: 19192300 (View on PubMed)

Other Identifiers

efno1008

Identifier Type: -

Identifier Source: org_study_id