Afentanil and Remifentanil for Anesthesia Quality and Recovery

NCT07761312 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: YXLL-KY-2026(148)
• Study Type: interventional
• Target: 990
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare two commonly used opioid pain medications-alfentanil and remifentanil-during general anesthesia for surgery, and to find out whether alfentanil is as good as (not worse than) remifentanil in keeping patients stable (steady blood pressure and heart rate) and adequately pain-free during the operation. The study will enroll adults aged 18-65 years who are in good to fair health (ASA class I-III) and are scheduled for elective non-cardiac, non-brain surgery lasting 1 to 4 hours with expected blood loss under 500 mL. The main questions it aims to answer are: How often do patients need extra painkillers or blood-pressure medications during surgery (a "rescue event") when receiving alfentanil compared with remifentanil? How quickly do patients wake up, breathe on their own, and get discharged from the recovery room after the operation? Do patients experience differences in pain levels, nausea, vomiting, or thinking/memory problems in the days after surgery? If there is a comparison group: Researchers will compare the alfentanil group with the remifentanil group to see if the rate of rescue events with alfentanil is not more than 8% higher than with remifentanil (the non-inferiority margin). Both groups will receive the same standard anesthetic (propofol and muscle relaxants) and the same postoperative pain management; only the study opioid differs. Participants will: Sign an informed consent form and undergo screening tests, including blood work, physical exam, and medical history review. Be randomly assigned (like a coin flip) to receive either alfentanil or remifentanil during their operation, with the drug given through an IV. Neither the patient nor the care team will know which drug is given until after the study is completed. Have their blood pressure, heart rate, breathing, and brain activity (using BIS monitors to measure depth of anesthesia) continuously tracked during surgery. After surgery, be followed for up to 3 days, during which they will be asked to rate their pain (using a simple 0-10 scale) and complete a short memory/thinking test (MMSE) at set times. Provide small blood samples before, right after, and 24 hours after surgery to measure stress hormones and inflammation markers. This study will involve about 990 patients across multiple hospitals and will take about 2 years to complete. The results will help doctors choose the best opioid for safer, smoother surgeries and faster recovery.

Conditions

Anesthesia Recovery Period ； Postoperative Pain； Hemodynamic Stability During Surgery

Keywords

Alfentanil；Remifentanil；Propofol TIVA；Non-inferiority；Hemodynamics；Postoperative pain；Recovery；Cognitive function

Outcome Measures

Primary Outcomes (1)

• Incidence of Intraoperative Rescue Events

  A composite endpoint defined as the need for rescue analgesia (administration of sufentanil \>5 μg intravenously) or rescue vasoactive medication (ephedrine, phenylephrine, norepinephrine, or esmolol) at any time during the surgical procedure, to manage inadequate analgesia or hemodynamic instability.

  From induction of anesthesia until the end of surgery (skin closure).

Secondary Outcomes (7)

• Recovery Times

  From the end of drug infusion until occurrence of each event (measured in the immediate post-anesthesia period).

• Postoperative Hyperalgesia

  Assessed during the postoperative period, up to 24 hours after surgery.

• Postoperative Pain Intensity (VAS)

  At 0.5, 2, 6, 12, and 24 hours after surgery.

• Incidence of Adverse Reactions within 24 Hours

  Within the first 24 hours following surgery.

• Total Propofol Consumption

  From induction of anesthesia until the end of surgery (skin closure).

Study Arms (2)

Alfentanil group

EXPERIMENTAL

patients receive alfentanil during surgery

Drug: alfentanil

Remifentanil group

ACTIVE COMPARATOR

Patients receive remifentanil during surgery

Drug: Remifentanil

Interventions

alfentanil DRUG

Alfentanil Hydrochloride Injection is administered intravenously for induction of general anesthesia at a single bolus dose of 30 μg/kg over 30 seconds, followed by a continuous intravenous infusion at a maintenance rate of 0.5-2.0 μg/kg/min, titrated stepwise by 0.3 μg/kg/min increments based on predefined hemodynamic triggers (heart rate or systolic blood pressure increase \>20% from baseline). The infusion is continued throughout surgery and discontinued precisely upon completion of skin closure. All participants in this arm also receive standardized propofol (via target-controlled infusion, Schnider model, Ce 2.5-3.5 μg/mL, BIS-guided 40-60), rocuronium for neuromuscular blockade, and uniform postoperative transitional analgesia (sufentanil 0.1 μg/kg IV) followed by patient-controlled intravenous analgesia (PCIA) with sufentanil/nalbuphine/ondansetron. The opioid infusion is the only differentiating factor between study arms

Alfentanil group

Remifentanil DRUG

Remifentanil Hydrochloride Injection is administered intravenously for induction at a single bolus dose of 1 μg/kg over 30 seconds, followed by a continuous infusion at 0.1-0.3 μg/kg/min during maintenance, titrated by 0.05 μg/kg/min increments using the same hemodynamic criteria. All other anesthetic, adjunctive, and postoperative analgesic regimens are identical to those in the alfentanil arm.

Remifentanil group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Congestive heart failure classified as NYHA Class II or above, or left ventricular ejection fraction (LVEF) \< 50%.
• (4) A history of cerebrovascular accidents (including ischemic and hemorrhagic strokes) or transient ischemic attacks within the past 6 months; (5) Uncontrolled severe hypertension: resting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (confirmed by repeated measurements); (6) Symptomatic aortic dissection, or lower limb arterial occlusion requiring treatment.(4) Severe blood system disorders, including but not limited to severe anemia, aplastic anemia, acute leukemia, thrombotic thrombocytopenic purpura, etc.
• (5) Difficulty in predicting airway management; (6) Pregnancy or lactation; (7) Allergy to opioids/propropofol/eggs/soybeans; (8) Participation in other clinical trials within the past 3 months.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Interventions

Alfentanil; Remifentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Jianbo Wu

CONTACT

0531-89269580; lizd1226@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Director of Department of Anesthesiology

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08