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

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: nitrogen; Drug: nitrous oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT00781352

efno1008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 408 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Acute bowel obstruction
• Minor colon surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 2 patient groups

group 1

Active Comparator group

Description:

Colorectal surgery with 65% nitrous oxide administration

Treatment:

Drug: nitrous oxide

group 2

Active Comparator group

Description:

Colorectal surgery with nitrogen administration

Treatment:

Drug: nitrogen