Subjective and objective evaluation of salivary secretion in oral surgery under general anesthesia.

UMIN ID: UMIN000054973

Registered date:16/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients over 20 years old who will undergo oral surgery under general anesthesia at Kanagawa Dental University Hospital.
• Date of first enrollment: 2024/07/16
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Anesthetic agents used in induction and maintenance of anesthesia in general anesthesia = Remimazolam
Anesthetic agents used in induction and maintenance of anesthesia in general anesthesia = Propofol
Anesthetic agents used in induction of general anesthesia = Propofol, and anesthetic agents used in maintenance of general anesthesia = Inhaled anesthetic agents.

Outcome(s)

• Primary Outcome: Subjective evaluation (salivation and discomfort) using Visual analogue scale from oral surgeon during pharyngeal pack insertion
• Secondary Outcome: 1. amount of saliva aspiration during tracheal intubation 2. subjective evaluation (salivation and stress) by dental anesthesiologist using Visual Analogue Scale during tracheal intubation

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. people with an ASA-PS of 3 or higher 2. patients who are aware of thirst or are taking drugs that cause thirst 3. patients who have the following on blood drawn prior to the preoperative visit AST (GOT) or ALT (GPT) greater than 100 IU/L Serum creatinine > 2.0 mg/dL HbA1c greater than or equal to 7.5 4. taking benzodiazepines for more than 6 months 5. whose EEG and BIS values may not be properly measured (including vascular lesions) 6. who have a cardiac pacemaker or ICD 7. who have expressed (including verbally) their refusal to participate in this study 8. other subjects deemed inappropriate by the principal investigator

Related Information

• Primary Sponsor: Kanagawa Dental University
• Source(s) of Monetary Support: Japan Society for the Promotion of Science