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

NCT07730918 | Completed

• 1 other identifier: 2025-018
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability During Anesthesia; Induction Anesthesia; Intubation

Keywords

Propofol; Alfentanil; Rapid sequence induction; Hemodynamic stability; Intubation stress

Outcome Measures

Primary Outcomes (3)

• Post-induction hypotension

  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.

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

• Substantial heart rate decline

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

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

• Inadequate blunting of intubation response

  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.

  Measured at T2 (immediately after intubation).

Secondary Outcomes (3)

• Intubating conditions

  Assessed at the time of tracheal intubation.

• Use of vasoactive agents

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

• Other adverse events

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

Study Arms (4)

Group A

EXPERIMENTAL

Propofol 1 mg/kg + Alfentanil 50 μg/kg + Rocuronium 0.6 mg/kg. Propofol administered first, followed by alfentanil over 10 seconds, then rocuronium. Tracheal intubation performed 1 minute after rocuronium.

Drug: propofol; Drug: alfentanil; Drug: Rocuronium

Group B

EXPERIMENTAL

Propofol 2 mg/kg + Alfentanil 30 μg/kg + Rocuronium 0.6 mg/kg. Same sequence as Group A (propofol first, then alfentanil, then rocuronium, intubation at 1 min).

Drug: propofol; Drug: alfentanil; Drug: Rocuronium

Group C

EXPERIMENTAL

Propofol 2 mg/kg + Sufentanil 0.5 μg/kg + Rocuronium 0.6 mg/kg. Sufentanil given over 30 seconds, followed by 4 minutes of mask ventilation, then propofol and rocuronium. Intubation 1 minute after rocuronium.

Drug: propofol; Drug: Sufentanil; Drug: Rocuronium

Group D

EXPERIMENTAL

Propofol 2 mg/kg + Alfentanil 50 μg/kg + Rocuronium 0.6 mg/kg. Same sequence as Group A (propofol first, then alfentanil, then rocuronium, intubation at 1 min).

Drug: propofol; Drug: alfentanil; Drug: Rocuronium

Interventions

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.

Group A; Group B; Group C; Group 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.

Group A; Group B; Group D

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

Group C

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.

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aoyang Hospital Affiliated to Jiangsu University: lead

Study Sites (1)

Aoyang Hospital Affiliated to Jiangsu University

Zhangjiagang, Jiangsu, 215600, China

Location

MeSH Terms

Interventions

Propofol; Alfentanil; Sufentanil; Rocuronium

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zhen Xu

  Aoyang Hospital Affiliated to Jiangsu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthesia nurse who assessed intubating conditions (Steyn modified Helbo-Hansen score) was blinded to the group allocation. Hemodynamic data were collected by a separate research nurse who was not involved in clinical management or subsequent data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Anesthesiologist

Model Details: Participants are allocated to one of four treatment groups based on the attending anesthesia team's routine clinical protocol, reflecting real-world practice. Allocation is determined by team shift schedules rather than patient-specific characteristics.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2025
• Primary Completion: May 30, 2026
• Study Completion: June 20, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)