Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy

NCT ID: NCT05895383

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-24
• Study Completion Date: 2025-01-30

Brief Summary

This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.

Detailed Description

Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally.

Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.

Conditions

Procedural Pain; Pain Catastrophizing; Procedural Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Self-adjusted nitrous oxide (SANO)

All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.

Group Type: EXPERIMENTAL

Nitrous oxide

Intervention Type: DRUG

Nitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control.

Interventions

Nitrous oxide

Nitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control.

Intervention Type: DRUG

Other Intervention Names

Self-adjusted nitrous oxide

Eligibility Criteria

Inclusion Criteria

1. Scheduled for vasectomy

2. Aged 21 to 85 years

3. Suitable for receipt of inhaled nitrous oxide/oxygen

4. Access to an email and computer

Exclusion Criteria

1. Perioral facial hair impeding good mask seal

2. Cognitive impairment that impedes ability to complete survey questions

3. Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy

4. Has any of the following medical conditions, which contraindicate use of nitrous oxide:

1. Inner ear, bariatric or eye surgery within the last 2 weeks,

2. Current emphysematous blebs,

3. Severe B-12 deficiency,

4. Bleomycin chemotherapy within the past year,

5. Heart attack within the past year,

6. Stroke within the past year,

7. Class III or higher heart failure.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Heidi Rayala

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heidi Rayala, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Marissa Kent, MD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Peter Steinberg, MD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heidi Rayala, MD, PhD

Role: CONTACT

hrayala@bidmc.harvard.edu

617-667-3739

Michelle Shabo, MD

Role: CONTACT

mshabo@bidmc.harvard.edu

Facility Contacts

Peter Healy

Role: primary

phealy1@bidmc.harvard.edu

Other Identifiers

2023P-000328

Identifier Type: -

Identifier Source: org_study_id