Sedation effects of alfentanil combined with cyclobenzaprine versus remazolam in fiberoptics bronchoscopy: a randomised controlled study

Sedation effects of alfentanil combined with cyclobenzaprine versus remazolam in fibreoptic bronchoscopy: a randomised controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400082469

Enrollment

Unknown

Registered

2024-03-29

Start date

2024-04-01

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Patients who are to undergo elective bronchoscopy and some simple bronchoscopic treatments

Interventions

Cyclopofol Group:Cypropofol + Alfentanil

Rimazolam group:Remazolam + Alfentanil

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) patients who are to undergo elective bronchoscopy and some simple bronchoscopic treatments (including transbronchial needle aspiration biopsy, transbronchial brushing, and bronchoalveolar lavage) (2) American Society of Anesthesiologists (ASA) class I-III; (3) aged 18-65 years; and (4) with a BMI of <28 kg/m2

Exclusion criteria

Exclusion criteria: (1) history of allergy to drugs involved in the study; (2) procedure time >30 minutes; (3) uncontrolled hypertension, diabetes mellitus, hyper- or hypothyroidism; (4) psychiatric disorders (e.g., schizophrenia, depression, etc.), history of epilepsy, and cognitive dysfunction; (5) previous history of abuse of psychotropic and narcotic medications; (6) abnormalities of hepatic, renal, and coagulation function; and (7) pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Hypoxaemia: SpO2100 beats/min;Bradycardia: HR <50 beats/minute;	—

Secondary

Measure	Time frame
Intraoperative airway manipulation of the patient (increased oxygen flow, jaw support, mask ventilation, tracheal intubation);Number of fibreoptic bronchoscope removals due to hypoxia;Number of successful sedation cases: successful sedation was defined as a BIS between 40-60 after induction of anaesthesia, smooth execution of the microscopy, and no postoperative recall by the patient;Time to induction of anaesthesia: time from first administration to first attainment of a MOAA/S score of less than 1 point;Time to awakening: time to BIS >80 and MOAA/S =4 after stopping medication;Time out of the room: time after admission to the PACU until Aldrete score =9 reaches the criteria for leaving the room;Use of remedial sedative drugs;Vasoactive drug use;Incidence of complications associated with fibreoptic bronchoscopy;Grading of airway response;Blood Pressure, Heart Rate, SPO2 and BIS;Satisfaction rating;	—

Measure

Time frame

Intraoperative airway manipulation of the patient (increased oxygen flow, jaw support, mask ventilation, tracheal intubation);Number of fibreoptic bronchoscope removals due to hypoxia;Number of successful sedation cases: successful sedation was defined as a BIS between 40-60 after induction of anaesthesia, smooth execution of the microscopy, and no postoperative recall by the patient;Time to induction of anaesthesia: time from first administration to first attainment of a MOAA/S score of less than 1 point;Time to awakening: time to BIS >80 and MOAA/S =4 after stopping medication;Time out of the room: time after admission to the PACU until Aldrete score =9 reaches the criteria for leaving the room;Use of remedial sedative drugs;Vasoactive drug use;Incidence of complications associated with fibreoptic bronchoscopy;Grading of airway response;Blood Pressure, Heart Rate, SPO2 and BIS;Satisfaction rating;

—

Countries

China

Contacts

Public ContactJie Zhao

Hangzhou Red Cross Hospital

zhaojie1014@zju.edu.cn+86 150 6882 9652

Outcome results

None listed

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