Adult caries
Conditions
Interventions
Propofol group:Propofol 1.5mg/kg and afentanil 5ug/kg were injected intravenously during the induction period, and afentanil 0.5ug/kg/min was injected intravenously during the maintenance period. The
Remazolam group:During the induction period of anesthesia, 0.15mg/kg of remazolam and 5ug/kg of afentanil were injected intravenously. During the maintenance period, 0.5ug/kg/min of afentanil was inje
Sponsors
Chinese People's Liberation Army Northern Theater Command General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects undergoing outpatient oral root canal treatment surgery 2. ASA grade I-II, age 18-70 years; 3. The anesthesia method is MAC anesthesia; 4. Estimated operation time =18 and =10 and =95% when absorbing air; SBP >=90 mmHg; DBP >=60 mmHg; Heart rate should be >=60 and <=100 beats per minute; 7. Able to understand the procedures and methods of this study, willing to sign informed consent and strictly abide by the clinical study protocol to complete this study.
Exclusion criteria
Exclusion criteria: 1. Those who have contraindications to deep sedation/general anesthesia or have a history of sedation/anesthesia accidents in the past; 2. Those who are known to be allergic to eggs, soy products, opioids and their antidotes, propofol, etc.; Propofol, opioids and their antidote contraindications; 3. Subjects with sensitive swallowing reflex and gag reflex; 4. History or evidence of the following that increases the risk of sedation/anesthesia prior to screening/at baseline: a) Cardiovascular history: uncontrolled hypertension [systolic blood pressure (SBP) >=170 mmHg and/or diastolic blood pressure (DBP)>=105 mmHg without antihypertensive medication, or SBP>160 mmHg and/or DBP>100 mmHg] after treatment with antihypertensive drugs, severe cardiac arrhythmias, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the past 6 months prior to screening, history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval >=450 ms (corrected by Fridericia's formula); b) Respiratory history: respiratory insufficiency, history of obstructive pulmonary disease, sleep apnea syndrome, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory infection within 1 week before the baseline period, and obvious symptoms such as fever, wheezing, nasal congestion and cough; c) History of cerebrovascular disease: history of craniocerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; History of schizophrenia, mania, mental disorder, long-term use of psychotropic drugs, cognitive dysfunction, etc.; d) History of gastrointestinal tract: gastrointestinal retention, active bleeding, may lead to reflux aspiration, etc.; e) Uncontrolled history of clinically significant diseases such as liver, renal, hematologic, nervous system, or metabolic system that the investigator judges may not be suitable for participation in the study; f) History of alcoholism, i.e., average daily alcohol consumption of >2 units of alcohol (1 unit = 360 mL of beer or 45 mL of liquor or 150 mL of wine) within 3 months prior to the screening period; g) History of substance abuse within 3 months prior to the screening period; 5. The following respiratory management risks were identified during the screening period: a) Those who have failed tracheal intubation; b) Difficulty in airway or tracheal intubation in the judgment of the investigator at screening (modified Marhalanobis score grade III-IV); 6. Screening period/baseline period found to have used any of the following medications or treatments: a) Those who have participated in any drug clinical study within 1 month prior to screening; b) Those who have used propofol, other sedative/anesthetic drugs and/or opioid analgesics or combination preparations containing analgesic components within 72 hours prior to baseline; 7. Those who meet the following criteria in the screening/baseline laboratory examination indicators and are confirmed by re-examination: a) Neutrophil count =2.5×ULN; e) total bilirubin > = 1.5×ULN; f) Serum creatinine >=1.2×ULN. 8. Subjects who, in the opinion of the investigator, have any other factors that are not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation success rate;Incidence of hypotension; | — |
Secondary
| Measure | Time frame |
|---|---|
| Age;Gender;Height and body mass index;Medication history;Hypertension history;History of diabetes;Smoking history;Drinking history;Restore sedation;Onset time;Postoperative recovery time;Full recovery time;Heart rate;Mean arterial pressure;Oxyhemoglobin saturation;Breathing amplitude and frequency;Depth of anesthesia;The number of intraoperative airway interventions;The dose of vasoactive drug used during operation;Hyoxemia;Intraoperative awareness;Respiratory depression;Bucking;Postoperative nausea and vomiting;Postoperative cognitive dysfunction/postoperative delirium;Heart rate;Mean arterial pressure;Oxyhemoglobin saturation;Breathing amplitude and frequency;Depth of anesthesia; | — |
Countries
China
Contacts
Public ContactYugang Diao
Chinese People's Liberation Army Northern Theater Command General Hospital
Outcome results
None listed