Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

NCT ID: NCT04305158

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-08-10

Brief Summary

Colon cancer is the second most common cancer in men and the third most common cancer in women worldwide. The clinical objectives of administering sedation for GI endoscopy are to relieve patient anxiety and discomfort and to improve the outcome of the examination. Use of N2O could potentially provide an alternate safe and cheap option for patients who do not prefer IV sedation for colonoscopy

Detailed Description

Patients who are considered low risk for anesthesia administration (ASA class <IV) receive moderate sedation with a combination of intravenous benzodiazepine and opioid medication. an alternative method of providing analgesia with "on-demand" inhalation of nitrous oxide (hereafter referred to as N2O) combined with oxygen has been postulated. Nitrous Oxide has been used for analgesia in various procedures including childbirth, general anesthesia, pediatric dentistry, bone marrow aspiration, fracture reductions, and minor surgical procedures (surgical dressings, pulmonary endoscopy, an abscess . It could potentially reduce overall costs for the procedure, in addition to providing a quicker recovery, turn over

Conditions

Nitrous Oxide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nitrous Oxide

Patient receiving Nitrous Oxide are evaluated for success of the procedure

Group Type: EXPERIMENTAL

Nitrous Oxide

Intervention Type: DRUG

Patient receiving nitrous oxide are evaluated for success of the procedure

IV Sedation group

In this group a combination of Midazolam and Fentanyl is used per endoscopic discretion

Group Type: ACTIVE_COMPARATOR

Nitrous Oxide

Intervention Type: DRUG

Patient receiving nitrous oxide are evaluated for success of the procedure

Interventions

Nitrous Oxide

Patient receiving nitrous oxide are evaluated for success of the procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Men and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit

Exclusion Criteria

• High ASA risk (IV/ >)
• History of chronic pain
• Allergy to N2O or opioid or BDZ
• No consent
• Recent head injury with impairment of consciousness or Intracranial / Middle Ear surgery within the previous 6 months with or without residual deficits.
• Pneumothorax, air embolism
• Decompression sickness or within 48 hours of an underwater dive
• Severe emphysema with bullae
• Gross abdominal distension with suspicion for bowel obstruction
• Intoxication
• Maxillofacial injuries (where patient unable to administer the drug using a mouthpiece/mask, or there is the risk of causing further damage to facial wounds and there may also be a significant risk of blood inhalation)
• Patients with chronic pulmonary disease for whom an inspired oxygen concentration of more than 28% oxygen might be dangerous
• Patients on Methotrexate
• Where patients need assistance to hold the mask or mouthpiece.
• Retinal surgery within the last three months
• Any patient who does not otherwise clinically qualify for standard sedation methods (i.e., those who require general anesthesia)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Dehmel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

239435

Identifier Type: -

Identifier Source: org_study_id