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Nitrous oxide inhalation sedation/analgesia for strabismus surgery

Efficacy and safety of nitrous oxide inhalation sedation/analgesia during strabismus surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1071240091
Enrollment
30
Registered
2024-12-27
Start date
2024-12-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strabismus

Interventions

In addition to the sub-Tenon anesthesia that is usually used for strabismus surgery, patients will be given inhalation of nitrous oxide and oxygen through a nasal cannula. There will be a low-concentr

Sponsors

Uematsu Masafumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing strabismus surgery under local anesthesia at the Ophthalmology Department of Nagasaki University Hospital 2. Patients aged 18 years or older (regardless of gender) at the time of obtaining consent 3. Patients who have received a full explanation of their participation in this study, fully understood the study, and have given their own voluntary written consent

Exclusion criteria

Exclusion criteria: 1. Patients with severe respiratory or circulatory diseases 2. Patients currently undergoing an asthma attack or with a history of severe asthma 3. Patients with vitamin B12 deficiency 4. Patients with impaired hematopoietic function 5. Patients with closed cavities in the body, such as tubal obstruction, pneumothorax, ileus, or pneumocephalus 6. Patients after ophthalmic surgery in which gases used for tamponade (perfluoropropane, sulfur hexafluoride, etc.) are present in the vitreous 7. Pregnant women 8. Patients currently participating in clinical trials or other clinical research 9. Patients who are otherwise deemed inappropriate as research subjects by the principal investigator

Design outcomes

Primary

MeasureTime frame
The primary outcome measures will be pain sensation during surgery and the presence or absence of nausea and vomiting.

Secondary

MeasureTime frame
Secondary endpoints will evaluate sedation due to nitrous oxide and the presence or absence of symptoms. Transcutaneous oxygen saturation, non-invasive blood pressure (systolic blood pressure, diastolic blood pressure), pulse rate, and respiratory rate are measured using a patient monitoring monitor, and the values are evaluated at the start, during the operation, and at the end. Side effects such as excessive excitement, excessive physical movement, discomfort, unpleasant fantasies or dreams, nausea, nausea, feeling sick, etc. are also evaluated. Additionary, pain sensation during eye washing is evaluated.

Contacts

Public ContactMasafumi Uematsu

Nagasaki University Hospital

uematsu@nagasaki-u.ac.jp+81-95-819-7345

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026