Effect of nitrous oxide on low PI status

JRCT ID: jRCT1011230007

Registered date:23/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peripheral hypoperfusion state
• Date of first enrollment: 23/05/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Administration of 50% nitrous oxide

Outcome(s)

• Primary Outcome: PI values before nitrous oxide administration, 30 minutes after administration, and 30 minutes after the end of administration.

Secondary Outcome

Central temperature (esophageal temperature), peripheral temperature (palm temperature), blood pressure, pulse rate, pre & post-load, cardiac output, oxygen saturation, and regional tissue oxygen saturation before nitrous oxide administration, 30 minutes after administration, and 30 minutes after the end of administration.
Central temperature, peripheral temperature, blood pressure, pulse rate, pre & post-load, Cardiac output, oxygen saturation, and regional tissue oxygen saturation every 5 minutes from before nitrous oxide administration to 30 minutes after the end of nitrous oxide administration.
Shivering after awakening.
Incidence of adverse events in the first 24 hours after surgery (hypoxic events (SpO2<92%), ischemic heart disease, stroke, nausea and vomiting, and number of antiemetic medications used).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients undergoing robotic and endoscopic surgery under general anesthesia for a scheduled time of 4 hours or more (e.g., including abdominal surgery, pulmonary surgery, endoscopic otolaryngology surgery, etc.)

Exclude criteria

Patients with PI less than 1.5% immediately after induction of general anesthesia.
Patients whose PI never fell below 1.5% intraoperatively.
Patients with unstable pulse oximeter in the fingers due to gangrene, nail disease, etc.
Patients with peripheral circulatory insufficiency in the extremities for PI measurement such as arteriosclerosis obliterans before surgery.
Patients who have difficulty inserting various other monitors (esophageal/palm thermometers, arterial pressure lines).
Patients who have suffered massive intraoperative bleeding and require not only temperature maintenance but also continued postoperative circulatory and respiratory management.
When consent cannot be obtained from the patient.
Patients who the anesthesiologist in charge judges that they are not suitable to participate in this study.

Related Information

• Primary Sponsor: Chaki Tomohiro