Nitrous oxide inhalation sedation/analgesia for strabismus surgery

JRCT ID: jRCT1071240091

Registered date:27/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Strabismus
• Date of first enrollment: 27/12/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: The primary outcome measures will be pain sensation during surgery and the presence or absence of nausea and vomiting.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Uematsu Masafumi