Hemodynamic Instability During Anesthesia, Induction Anesthesia, Intubation
Conditions
Keywords
Propofol; Alfentanil; Rapid sequence induction; Hemodynamic stability; Intubation stress
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.
Interventions
DRUGpropofol
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.
DRUGalfentanil
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.
DRUGSufentanil
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
DRUGRocuronium
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.
Sponsors
Aoyang Hospital Affiliated to Jiangsu University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-induction hypotension | 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. |
| Substantial heart rate decline | 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. |
| Inadequate blunting of intubation response | 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
| Measure | Time frame | Description |
|---|---|---|
| Other adverse events | 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. |
| Intubating conditions | 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. |
| Use of vasoactive agents | 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. |
Countries
China
Contacts
STUDY_DIRECTORZhen Xu
Aoyang Hospital Affiliated to Jiangsu University
Outcome results
None listed