Hemodynamic Instability During AnesthesiaNCT07730918
Low-dose Propofol Plus High-dose Alfentanil in Rapid Sequence Induction
A study testing propofol, alfentanil and Sufentanil in people with Hemodynamic Instability During Anesthesia and Induction Anesthesia, run by Aoyang Hospital Affiliated to Jiangsu University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemodynamic Instability During Anesthesia, Induction Anesthesia, Intubation
- What is being tested?
- propofol, alfentanil and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Hypertension, diabetes mellitus, or cardiopulmonary dysfunction
- Difficult airway
- History of anesthetic drug allergy
- Chronic sedative or analgesic use
- Preoperative volume depletion
- Overt painful stimuli
Trial locations and contacts
1 site in 1 country.
China1 site
Aoyang Hospital Affiliated to Jiangsu University
Zhangjiagang, Jiangsu, 215600
About this study
Official title: Efficacy and Hemodynamic Safety of Low-dose Propofol Plus High-dose Alfentanil in Rapid Sequence Induction: A Prospective Non-randomized Interventional Study
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.
- Being tested
- propofol, alfentanil, Sufentanil, Rocuronium
- Keywords
- Propofol; Alfentanil; Rapid sequence induction; Hemodynamic stability; Intubation stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
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.
alfentanilDrug
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.
SufentanilDrug
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
RocuroniumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: 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). Receives: Drug: propofol; Drug: alfentanil; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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: Measured at T2 (immediately after intubation).
Secondary outcomes (3)
Intubating conditions
Intubating conditions assessed by the Steyn modified Helbo-Hansen score, range 5 to 20, with 5 representing optimal conditions.
Measured: Assessed at the time of tracheal intubation.
Use of vasoactive agents
Use of vasoactive agents (e.g., atropine, urapidil) during the observation period T1-T5.
Measured: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).
Other adverse events
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.
Measured: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2025
- Primary completion30 May 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic Instability During AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aoyang Hospital Affiliated to Jiangsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Xu, Aoyang Hospital Affiliated to Jiangsu University
- Investigators
- Zhen Xu, Study director, Aoyang Hospital Affiliated to Jiangsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730918
- Sponsor's protocol ID
- 2025-018
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study did not receive specific funding to support data sharing, and no informed consent for data sharing was obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Hemodynamic Safety of Low-dose Propofol Plus High-dose Alfentanil in Rapid Sequence Induction: A Prospective Non-randomized Interventional Study
- ClinicalTrials.gov ID
- NCT07730918
- Acronym / sponsor ID
- 2025-018
- Keywords
- Propofol; Alfentanil; Rapid sequence induction; Hemodynamic stability; Intubation stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Aoyang Hospital Affiliated to Jiangsu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: propofol, Drug: alfentanil, Drug: RocuroniumPropofol 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. |
| Group B | Experimental | Drug: propofol, Drug: alfentanil, Drug: RocuroniumPropofol 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). |
| Group C | Experimental | Drug: propofol, Drug: Sufentanil, Drug: RocuroniumPropofol 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. |
| Group D | Experimental | Drug: propofol, Drug: alfentanil, Drug: RocuroniumPropofol 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Hypertension, diabetes mellitus, or cardiopulmonary dysfunction
- Difficult airway
- History of anesthetic drug allergy
- Chronic sedative or analgesic use
- Preoperative volume depletion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolPropofol 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. | Drug | Group A, Group B, Group C, Group D |
| alfentanilAlfentanil 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. | Drug | Group A, Group B, Group D |
| SufentanilSufentanil 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 | Drug | Group C |
| RocuroniumRocuronium 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. | Drug | Group A, Group B, Group C, Group D |
Primary outcome
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.
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.
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.
3 secondary outcomes
Intubating conditions
Time frame: Assessed at the time of tracheal intubation.
Use of vasoactive agents
Time frame: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).
Other adverse events
Time frame: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. The study did not receive specific funding to support data sharing, and no informed consent for data sharing was obtained from participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Xu study director
Aoyang Hospital Affiliated to Jiangsu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol, alfentanil and Sufentanil in people with Hemodynamic Instability During Anesthesia and Induction Anesthesia, run by Aoyang Hospital Affiliated to Jiangsu University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-induction hypotension (time frame: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.