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NCT Number: NCT07730918

Low-dose Propofol Plus High-dose Alfentanil in Rapid Sequence Induction

This study compares four different anesthesia induction regimens to see which one provides the most stable blood pressure and heart rate during rapid sequence intubation. A total of 172 patients undergoing elective surgery will receive one of four combinations of propofol and opioids (alfentanil or sufentanil). The main outcomes are hypotension (low blood pressure), inadequate blunting of the stress response to intubation, and intubating conditions. The study aims to determine whether a lower dose of propofol combined with a higher dose of alfentanil can improve hemodynamic stability without compromising the quality of tracheal intubation.

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Key information

Conditions

Hemodynamic Instability During Anesthesia Induction Anesthesia Intubation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aoyang Hospital Affiliated to Jiangsu University

Zhangjiagang, Jiangsu, 215600, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I or II
  • Age 18 to 60 years
  • Body mass index (BMI) 18 to 30 kg/m²
  • Scheduled for elective surgery at Aoyang Hospital Affiliated to Jiangsu University

Exclusion criteria

  • Hypertension, diabetes mellitus, or cardiopulmonary dysfunction
  • Difficult airway
  • History of anesthetic drug allergy
  • Chronic sedative or analgesic use
  • Preoperative volume depletion
  • Overt painful stimuli

Treatment and study plan

Propofol

Drug

Propofol is a short-acting intravenous hypnotic agent used for induction of general anesthesia. In this study, it is administered at 1 mg/kg in Group A and 2 mg/kg in Groups B, C, and D.

alfentanil

Drug

Alfentanil is a short-acting synthetic opioid with rapid blood-brain equilibration (t½ke0 ≈ 1.0-1.5 min). It is administered at 50 μg/kg in Groups A and D, and 30 μg/kg in Group B, all by intravenous injection over 10 seconds.

Sufentanil

Drug

Sufentanil is a synthetic opioid with slower equilibration compared to alfentanil. It is administered at 0.5 μg/kg by intravenous injection over 30 seconds in Group C only, followed by 4 minutes of mask ventilation before propofol induction

Rocuronium

Drug

Rocuronium is a non-depolarizing neuromuscular blocking agent. It is administered at 0.6 mg/kg intravenously in all four treatment groups to facilitate tracheal intubation.

Primary outcomes

  1. Post-induction hypotension

    Time frame: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).

    Mean arterial pressure (MAP) < 60 mmHg for at least 2 consecutive time points during T1-T5. MAP < 50 mmHg at any time point is recorded separately as severe hypotension.

  2. Substantial heart rate decline

    Time frame: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).

    Maximum decrease in heart rate (HR) ≥ 20% from the baseline value (T0) during T1-T5.

  3. Inadequate blunting of intubation response

    Time frame: Measured at T2 (immediately after intubation).

    Meeting either of the following criteria at T2: (a) HR > T0 × 1.2 and MAP ≥ T0 × 0.85 (i.e., MAP decline <15%), excluding reflex tachycardia secondary to hypotension; or (b) MAP > T0 × 1.2.

Secondary outcomes

  1. Intubating conditions

    Time frame: Assessed at the time of tracheal intubation.

    Intubating conditions assessed by the Steyn modified Helbo-Hansen score, range 5 to 20, with 5 representing optimal conditions.

  2. Use of vasoactive agents

    Time frame: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).

    Use of vasoactive agents (e.g., atropine, urapidil) during the observation period T1-T5.

  3. Other adverse events

    Time frame: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).

    Adverse events reported descriptively, including hypertensive response to intubation (systolic blood pressure at T2 elevated by >30% above T0), body movement, coughing, lacrimation, and vagal reflexes.

Sponsors and collaborators

Lead sponsor

Aoyang Hospital Affiliated to Jiangsu University

Other

Registry information

Official study title

Efficacy and Hemodynamic Safety of Low-dose Propofol Plus High-dose Alfentanil in Rapid Sequence Induction: A Prospective Non-randomized Interventional Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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