obstructive sleep apnea syndrome
Conditions
Interventions
Group C:topical anesthesia + remifentanil
Group M:topical anesthesia + remifentanil + midazolam
Group R:topical anesthesia + remifentanil + ramidazolam
Sponsors
Chancheng District Central Hospital, Foshan, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old men and women; 2. Preoperative diagnosis of obstructive sleep apnea syndrome patients undergoing elective surgery (tracheal intubation mechanical ventilation); 3. The American Society of anesthesiologists (ASA) was classified as I~III; 4. Body Mass Index(BMI)> 20 kg/ m2; 5. The patient or family members fully understand the purpose and significance of this experiment, and voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) With severe diseases of the heart, brain,lung and vascular system ; resting ECG heart rate or less 50 times/min; III degree atrioventricular block, QTc: male >=450 ms, female >=470 ms; (2) Patients with liver dysfunction:ALT or ALT >=2.5 times of the upper limit of normal value TBIL>=1.5 times of the upper limit of normal value; (3) Patients with kidney dysfunction: BUN >=1.5 ULN, serum creatinine (CR) >=ULN; (4) Blood pressure of Hypertensive patients is not satisfactorily controlled (sitting position systolic blood pressure >=160 mmHg,or=100 mmHg,) during the screening period; (5) Patients with history of drug abuse or alcohol abuse , alcoholism means more than 2 units of alcohol per day Alcohol (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); (6) Patients with mental system diseases, Long-term history of taking psychotropic drugs and cognitive dysfunction (7) Pregnancy or lactation patients; (8) Patients who are allergic or contraindicated to research drugs and their components including benzodiazepine, opioid, and flumazenil; (9) Patients with mouth opening less than 1 cross finger and oral deformities that cannot be placed by Skikani. (10) Participated in other intervention clinical trials within 3 months before administration; (11) The researcher think not suitable for this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| success rates of sedation; | — |
Secondary
| Measure | Time frame |
|---|---|
| induction time;the first intubation success rate;tracheal intubation time;Blood Pressure;Heart rate;pulse oxygen saturation;Modified Observer’s Assessment of Alertness/Sedation;Nacotrend values;numerical rating scale;Incidence of respiratory depression during sedation; | — |
Countries
China
Contacts
Public ContactYingchao Xie
Department of Anesthesiology, Chancheng District Central Hospital, Foshan, China
Outcome results
None listed