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Nitrous Oxide for Pain Management During In-Office Gynecology Procedures

NCT06661005 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-10-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pain control, patient satisfaction, and efficiency of nitrous oxide used for anesthesia during in-office gynecologic procedures compared to IV sedation. IV sedation for office-based gynecology procedures provides effective anesthesia but requires a recovery time, IV placement, and a ride provided for the patient. Nitrous oxide can be a viable alternative to IV sedation while also reducing recovery time and omitting the need for an IV, NPO status, and a ride home.

Conditions

  • Nitrous Oxide

Interventions

DRUG

Nitrous oxide

The Nitrous oxide group will receive instructions to arrive at clinic 30 minutes before her procedure in order to sign consent forms. She will not be given instructions to remain NPO and will not be required to have someone bring her to and from the appointment. No IV will be placed. Anesthesia induction will be done by an anesthesiologist with a nitrous oxygen mixture at a 70:30 ratio

DRUG

IV Sedation

Anesthesia induction will be done by an anesthesiologist with propofol per standard protocol. A pulse oximeter will be placed and oxygen will be administered through a nasal cannula and the patient will be instructed to breath.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-09-01
Completion
2021-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661005 on ClinicalTrials.gov