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Effectiveness of dexmedetomidine nasal drops in combination with rimazolam for bronchoscopy

Effectiveness of dexmedetomidine nasal drops in combination with rimazolam for bronchoscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070647
Enrollment
Unknown
Registered
2023-04-19
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Effectiveness of dexmedetomidine nasal drops in combination with rimazolam for bronchoscopy

Interventions

Sponsors

Min Dong Hospital affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. patients undergoing elective painless bronchoscopy; 2. age 18-65 years, gender not limited; 3. American Society of Anesthesiologists (ASA) class I-III; 4. body mass index (BMI) >= 18 and = 93%, 90 <= SBP <= 160 mmHg, 60 <= DBP<=100mmHg, 55<=HR<=100 beats/min; 6. Patients could understand the process and methods of this study and voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: (1) Persons with contraindications to general anesthesia or a previous history of anesthetic accidents. (2) Known or suspected allergy to dexmedetomidine and remazolam, opioids, myorelaxants, etc. (3) Having an acute upper respiratory tract infection or acute severe laryngeal disease, being in an asthma attack, etc. (4) History of gastrointestinal disease: gastrointestinal retention, active bleeding, conditions that may lead to reflux aspiration, etc. (5) History of craniocerebral injury, intracranial hypertension, stroke, cerebrovascular accident, epilepsy, etc. (6) The presence of respiratory insufficiency, obstructive pulmonary disease, difficult airway, etc. (modified marsupial classification of grade III or IV) (7) Presence of uncontrolled hypertension, hypotension, and diabetes mellitus, etc. (8) The presence of severe cardiac arrhythmias, heart failure, unstable angina pectoris, myocardial infarction, etc. (9) The presence of severe liver insufficiency and severe renal insufficiency (10) Have a history of alcoholism, drug abuse and drug dependence (11) Abuse or long-term application of narcotic sedation, narcotic analgesic drugs, etc. (12) Have a history of mental illness; (12) Have a history of mental illness (13) have participated in any drug clinical trials within 3 months prior to screening (14) Pregnant and lactating women, women of childbearing potential, or men who are unwilling to use contraception throughout the trial period and have a pregnancy plan within 1 month of the trial (including male subjects) (15) Conditions that contraindicate the use of nasopharyngeal ventilation tubes, such as combined nasal airway obstruction, nasal bone fracture, nasal trauma, nasal polyps, nasal bleeding, significant nasal septal deviation, severe abnormalities in coagulation or the presence of bleeding tendencies (16) The presence of conditions that contraindicate the use of noninvasive arterial blood pressure monitoring, such as the presence of anatomical abnormalities on the radial side of the wrists of both hands (skin grafts, cysts, cellulitis), or injuries (scars, wounds, burns, abrasions). (17) The presence of any other condition that, in the opinion of the investigator, makes participation in this trial inadvisable.

Design outcomes

Primary

MeasureTime frame
The incidence of cough;

Secondary

MeasureTime frame
Frequency and degree of cough;Vital signs;Duration of successful induction of anesthesia (time from first start of study drug administration to MOAA/S = 1);Duration of fully conscious ;Duration of leaving the operating room;Frequency of face mask positive pressure ventilation with lower jaw raised;Total medication use;Ambesh Injection pain grade;Adverse reactions;Satisfaction;

Countries

China

Contacts

Public ContactHuang Qingqing

Min Dong Hospital, Fujian Medical University

494325099@qq.com+86 13599198422

Outcome results

None listed

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