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The efficacy and safety of propofol combined with sufentanil in fiberoptic bronchoscopy: a prospective, randomized, double-blind, non inferiority trial

The efficacy and safety of propofol combined with sufentanil in fiberoptic bronchoscopy: a prospective, randomized, double-blind, non inferiority trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080957
Enrollment
Unknown
Registered
2024-02-19
Start date
2024-03-25
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Patients undergoing soft fiber bronchoscopy

Interventions

Cyclopol group:Administer cyclophenol
Propofol group:Administer propofol

Sponsors

The Fourth Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 18 to 65 years old, regardless of gender; (2) No tracheal intubation or mechanical ventilation; (3) According to the American Society of Anesthesiologists, patients are classified into I-III levels based on their physical condition and surgical risk before anesthesia. (4) Blood oxygen saturation under air conditions is greater than 93%.

Exclusion criteria

Exclusion criteria: (1) Within 2 weeks prior to surgery, receiving drugs that may affect the QT interval or induce/inhibit cytochrome P450 (especially CYP2B6) enzymes; (2) Have a history of alcohol or drug abuse; (3) Known to be allergic to eggs, soy products, or propofol, propofol, or sufentanil; (4) Have a history of anesthesia surgery with previous abnormal resuscitation; (5) Body mass index greater than 30 kg/m2; (6) Difficult airway; Anesthesiologists with over five years of clinical anesthesia experience may encounter difficulties during mask ventilation (upper respiratory obstruction), tracheal intubation, or a combination of both clinical conditions. (7) Pregnancy, lactation, or breastfeeding; (8) Have a history of severe heart, brain, lung, liver, kidney or metabolic diseases; (9) Participate in other clinical trials three months prior to fiberoptic bronchoscopy examination.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
demographics;Time measurement;hemodynamics; Intubation conditions;Study the use of drug dosage; The quantity of remedial drugs;Satisfaction of patients and endoscopists; Injection pain incidence rate;The incidence of adverse electrocardiogram events;The incidence of other adverse events;Anesthesia trend value;MOAA/S score;

Countries

China

Contacts

Public ContactZhu Yana

The Fourth Affiliated Hospital of Harbin Medical University

2391234775@qq.com+86 131 3668 3638

Outcome results

None listed

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