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

Nitrous oxide inhalation sedation/analgesia for strabismus surgery

Uematsu Masafumi

Nagasaki University Hospital

1-7-1 Sakamoto Nagasaki-City Nagasaki

uematsu@nagasaki-u.ac.jp

Uematsu Masafumi

Nagasaki University Hospital

1-7-1 Sakamoto Nagasaki-City Nagasaki

+81-95-819-7345

uematsu@nagasaki-u.ac.jp

Recruiting

Dec. 27, 2024

Interventional

randomized controlled trial

open(masking not used)

placebo control

parallel assignment

treatment purpose

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

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

Both

Strabismus

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-concentration (30%) nitrous oxide group and a control group, which will receive only oxygen.

D013285

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

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.

+81-95-819-7229

Dec. 18, 2024

Yes

The principal investigator and other researchers involved in this study may use the samples and information obtained in this study for different research purposes or provide them to other research institutions. In that case, a new research plan will be prepared, and the study will be started in accordance with the procedures of the research institution after review and approval by a review committee or other committee that should hear opinions on this study. Informed consent will be obtained in an appropriate manner according to the content of the study.

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