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Efficacy and safety of a new endoscopic nasal mask in intravenous anesthesia with respiratory retention: a single blind, randomized, positive, contralateral, controlled clinical trial

Efficacy and safety of a new endoscopic nasal mask in intravenous anesthesia with respiratory retention: a single blind, randomized, positive, contralateral, controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032584
Enrollment
Unknown
Registered
2020-05-03
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyoxemia

Interventions

Intravenous anesthesia group 2: Laryngeal Mask Airway
Intravenous anesthesia group 1:New endoscopic nasal mask

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1)The age 18-70 years old; (2) Urological surgery or gynecologic surgery (urology: bladder calculi; Gynecology: hysteroscopy) of the patient; (3) 18Kg/m2 <= BMI <= 28Kg/m2; (4) ASA(American society of anesthesiologists) I-III; (5) Able to understand the research process and communicate effectively with researchers; (6) Volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Abnormal liver function (ALT or AST > 2 x ULNor TBIL >= 1.5 x ULN); (2) Renal injury(serum creatinine > 112µmol/L), or received dialysis treatment within 28 days before surgery; (3) Patients with active upper respiratory tract infection or pneumonia; (4) During the screening period, the resting electrocardiogram of the patient was obviously abnormal, and the researcher determined that the patient was not suitable for the test; (5) Antihypertensive drugs were used to treat hypertensive patients whose blood pressure was not satisfactorily controlled (Sitting systolic pressure during screening >= 160mmHg; and/or Diastolic blood pressure screening period >= 105mmHg); (6) Diabetic patients with unsatisfactory control of blood glucose (Fasting blood glucose during screening >= 11mmol/L); (7) Patients at high blood risk, including those taking anticoagulant and antiplatelet drugs, Patients with congenital haemorrhagic diseases (e.g. hemophilia), thrombocytopenia(PLT < 50 x10^9/L). Patients with platelet dysfunction (e.g. idiopathic thrombocytopenic purpura diffuse intravascular coagulation congenital platelet dysfunction) or patients with clinically significant bleeding under any activity; (8) Patients with neck injuries who are at risk for neck instability (such as rheumatoid arthritis or down's syndrome) or who have reduced neck range of motion, limited mouth opening, oropharyngeal structural abnormalities, and vertebral artery occlusion; (9) Participated in other clinical trials in 30 days; (10) Patients with existing sore throat; (11) Patients with chronic respiratory disease or hyperreactive airway disease; (12) Patients with underlying airway obstruction (e.g., obstructive sleep apnea, abnormal tonsil enlargement, airway compression, tracheomalacia, pharyngeal tumor, abscess, hematoma, etc.); (13) Patients with satiety, increased abdominal pressure, tendency of vomiting reflux aspiration (such as obesity, hiatal hernia, pregnancy, autonomic nerve dysfunction), inertia vomiting patients; (14) Surgery has strict muscle relaxation requirements in patients; (15) The expected operation time is more than 1 hour; (16) Other reasons why the researchers considered it inappropriate to participate.

Design outcomes

Primary

MeasureTime frame
The incidence of hypoxemia;pulse oxygen saturation;

Secondary

MeasureTime frame
pharyngalgia;laryngospasmus;Reflux aspiration;pulmonary edema;

Countries

China

Contacts

Public ContactYu Bin

Shanghai Tongji Hospital

yubin@tongji.edu.cn+86 13918108880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026