Can Nitrous Oxide (Laughing Gas) be Used as a Sedative for GI Endoscopy Procedures?

NCT ID: NCT05396144

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-01-01

Brief Summary

Nitrous oxide (commonly known as 'laughing gas') is often used during dental and other outpatient procedures, because it is easy to administer, is short-acting and rapidly clears from the body following the procedure.

The investigators hypothesize that use of Nitrous oxide during GI endoscopy may enhance patient comfort during the procedure and speed-up post-procedure recovery, while minimizing the fatigue and mental fogginess some patients report the day after receiving standard sedative and narcotic drugs used routinely for the procedure.

The investigators are interested in determining if adding Nitrous Oxide to commonly used sedation drugs will decrease fatigue, mental fogginess, and nausea/vomiting, as well as determine when the patient felt fully recovered from the effects of all sedatives given for the procedure.

Conditions

Endoscopy; Colonoscopy

Study Design

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

Study Groups

5% inhaled nitrous oxide

Patients will received 5% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.

Group Type: SHAM_COMPARATOR

Nitrous oxide

Intervention Type: DRUG

Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient

50% inhaled nitrous oxide

Patients will received 50% nitrous oxide by face mask in addition to standard intravenous sedatives given at the discretion of the care provider.

Group Type: ACTIVE_COMPARATOR

Nitrous oxide

Intervention Type: DRUG

Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient

Interventions

Nitrous oxide

Nitrous oxide will be administered by face or nasal mask to be inhaled by the patient

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-pregnant patients age 18 and older
• Patient's presenting for upper endoscopy or colonoscopy under endoscopist- directed nurse sedation.
• Patient is willing and able to consent and comply with study procedures.

Exclusion Criteria

• Age <18
• Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
• Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
• Allergy to the proposed anesthetic agents (e.g. nitrous oxide, midazolam, fentanyl, diphenhydramine)

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

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Tim Angelotti

Associate Professor of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University Hospital

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Tim Angelotti, MD, PhD

Role: primary

timangel@stanford.edu

650-498-7525

Other Identifiers

54961

Identifier Type: -

Identifier Source: org_study_id