Use of Nitrous Oxide During Office Hysteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-06-30

Brief Summary

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The goal of this clinical trial is to assess the use of inhaled nitrous oxide during office hysteroscopy.

The main questions it aims to answer are:

* Does it reduce pain during the procedure?
* Does it increase the success rate?
* Does it improve patient satisfaction?
* Does it reduce anxiety?
* Which populations benefit more (e.g., parity, menopausal status, number of previous surgeries, type and duration of procedure, and type of device)?

Participants will be asked about their pain levels during the procedure, as well as their anxiety levels. All responses will be recorded.

Written informed consent will be obtained prior to initiation.

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Detailed Description

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Office hysteroscopy offers a convenient alternative to operating room-based procedures, yet many patients experience pain and anxiety significant enough to interfere with procedural completion. Nitrous oxide is a fast-acting inhaled agent with both analgesic and anxiolytic properties, widely used in outpatient settings across various medical specialties.

This study will investigate the role of nitrous oxide in improving patient tolerability and comfort during office hysteroscopy. Participants will undergo a standardized procedural protocol with either nitrous oxide or ambient air administered via a demand-valve mask system. Comprehensive data on patient responses during the procedure will be collected and analyzed.

The study will also examine variability in patient responses across different subgroups and procedural types. All procedures will adhere to ethical standards, and patient confidentiality will be maintained throughout.

Conditions

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Abnormal Uterine Bleeding Postmenopausal Bleeding Endometrial Polyps Retained Products of Conception Uterine Fibroids Intrauterine Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized clinical trial of inhaled nitrous oxide vs inhaled ambient air

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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treatment- inhaled nitrous oxide

Participants in the Nitrous Oxide group will inhale a fixed 50:50 mixture of nitrous oxide (N₂O) and oxygen (O₂), starting one minute prior to the procedure and continuing throughout its duration.

The gas is administered via a self-administered demand-valve face mask connected to the Blendox system (Ambulanc®, Italy).

Group Type ACTIVE_COMPARATOR

Inhalation of Nitrous Oxide (N₂O) during Office Operative Hysteroscopy

Intervention Type PROCEDURE

Inhaled nitrous oxide

Inhaled ambient air control group

Participants in the control group will inhale ambient air starting one minute prior to the procedure and will continue inhalation throughout its duration.

The ambient air is administered via a self-administered demand-valve face mask connected to the Blendox system (Ambulanc®, Italy).

Group Type PLACEBO_COMPARATOR

inhalation of ambient air during office hysteroscopy

Intervention Type PROCEDURE

inhalation of ambient air

Interventions

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Inhalation of Nitrous Oxide (N₂O) during Office Operative Hysteroscopy

Inhaled nitrous oxide

Intervention Type PROCEDURE

inhalation of ambient air during office hysteroscopy

inhalation of ambient air

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Women aged ≥18 years Scheduled to undergo operative office hysteroscopy for clinical indications

Exclusion Criteria

Any contraindications to N₂O, including:

Pneumothorax Significant chronic obstructive pulmonary disease (COPD) Upper airway obstruction Bowel obstruction Middle ear pathology (e.g., recent ear surgery or active ear infection) Severe recent intraocular gas injection Severe vitamin B12 deficiency Known hypersensitivity to N₂O

Women who will decline randomization or unable to provide informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No