Efficacy and safety of remiazolam combined with remifentanil hydrochloride in painless bronchoscopy

Efficacy and safety of remiazolam combined with remifentanil hydrochloride in painless bronchoscopy: a single center, prospective, randomized, single blind, controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300069905

Enrollment

Unknown

Registered

2023-03-29

Start date

2023-04-01

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

painless bronchoscopy

Interventions

RR group:Remazolam besylate combined with remifentanil

PR group:Propofol combined with remifentanil

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients receiving elective painless tracheoscopy; 1) Patients receiving elective painless tracheoscopy 2) Age 18~65, regardless of gender; 3) Body mass index (BMI): 18~30 kg · m^2; 4) American Society of Anesthesiologists (ASA): I~III; 5) The operation time is within 60 min; 6) Vital signs: RR 10-24 bpm; SpO2 >= 93% when absorbing air; SBP 90~160mmHg; DBP 60~100 mmHg; HR 55~100 bpm; 7) Subjects voluntarily participated in the trial and signed the informed consent form of the trial.

Exclusion criteria

Exclusion criteria: 1) Subjects explicitly refused to participate in this study; 2) Allergies to opiates, benzodiazepines, propofol, flumazenil or naloxone excipients; 3) Using ß Receptor blockers, antianxiety drugs, antidepressants; 4) People suspected of abusing narcotic analgesics or sedatives, and alcoholics; 5) ECG showed that the heart rate was100 bpm or there was serious arrhythmia; 6) Acute respiratory tract infection without cure within 2 weeks; 7) Patients with a history of serious heart, brain, lung, liver, kidney or metabolic diseases, and neuromuscular systemSystemic diseases (such as myasthenia gravis) and mental diseases; 8) SBP>180 mmHg and/or DBP>110 mmHg in patients with preoperative hypertension, or Patients with hypotension<90/60 mmHg; 9) Previous history of abnormal surgical anesthesia recovery; 10) Predict that difficult airways may occur or have occurred, such as modified Markov classification III-IV; 11) Pregnant or lactating women and patients (including men) with birth plans within 3 months; 12) Other subjects that other researchers think are not suitable to participate in this study.

Design outcomes

Primary

Measure	Time frame
Incidence of intraoperative respiratory depression;	—

Secondary

Measure	Time frame
Percentage of successful operations;Safety indicators;Satisfaction score;	—

Countries

China

Contacts

Public ContactLin Xianzhong

The First Affiliated Hospital of Fujian Medical University

724165640@qq.com+86 135 0935 0812

Outcome results

None listed

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