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Efficacy and safety of alfentanil combined with propofol during fiberoptic bronchoscopy: a multicenter, randomized, double-blind, controlled trial

Efficacy and safety of alfentanil combined with propofol during fiberoptic bronchoscopy: a multicenter, randomized, double-blind, controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041885
Enrollment
Unknown
Registered
2021-01-09
Start date
2021-01-11
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

fiberoptic bronchoscopy

Interventions

Experimental group:Alfentanil was administered at 10 µg/kg during the induction period. Propofol was infused with target-controlled infusion (plasma concentration mode) after 2 min. The initial rate w
control group:Sufentanil was administered at 0.1 µg/kg during the induction period. Propofol was infused with target-controlled infusion (plasma concentration mode) after 2 minutes. The initial rate w

Sponsors

Taizhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients who intend to undergo fiberoptic bronchoscopy; 2) Aged 18-75 years, no gender limit; 3) American Association of Anesthesiologists (ASA): Level I-III; 4) Body mass index (BMI): 18.5~30 kg/m2; 5) Volunteer to participate and signed an informed consent.

Exclusion criteria

Exclusion criteria: 1) People with chronic pain who have used analgesics, psychotropic drugs (including opioids, NSAIDs, sedatives, and antidepressants), alcohol abusers for a long time. 2) The liver and kidney functions (ALT, AST, BUN, Cr) are abnormally increased before surgery, which is more than 1.5 times the normal value. 3) A history of abnormal surgical anesthesia recovery. 4) In the past or at present, patients had hypertension which could not be controlled by drugs, or systolic blood pressure >= 170 mmHg or diastolic blood pressure >= 100 mmHg during the screening period. 5) Suffer from esophageal reflux disease. 6) Sedatives, antiemetics, and antipruritic drugs were used 24 hours before the operation. 7) Expected to be difficult intubation. 8) A history of opioid allergy. 9) Take monoamine oxidase inhibitors or antidepressants within 15 days. 10) Shock patients. 11) Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). 12) Pregnant or parturient. 13) Participated in other drug trials within three months. 14) Other patients considered by researchers to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative respiratory depression;

Secondary

MeasureTime frame
Severity of coughing during induction;Time from the start of administration to the appearance of coughing;total amount of propofol and lidocaine use times and total amount during operation;Blood pressure;Heart Rate;SPO2;PETCO2;Ramsay score;Respiratory rate;Lethargy;Recovery time after operation;Postoperative nausea and vomiting;Satisfaction of anesthesiologists, bronchoscopy operators and patients with the effect of anesthesia;

Countries

China

Contacts

Public ContactSun Canlin

Taizhou People's Hospital

shcltz286@hotmail.com+86 13912196199

Outcome results

None listed

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