General AnesthesiaNCT07716891
Effect of Pre-injection of Rocuronium on Neuromuscular Blockade Onset Time and Hemodynamics During General Anesthesia Induction
A study testing Rocuronium Bromide (Pretreatment Injection) and Rocuronium Bromide (Conventional Injection) in people with General Anesthesia and Elective Surgery, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
This is a single-center, prospective, randomized, controlled trial comparing pre-injection versus standard bolus administration of rocuronium bromide for general anesthesia induction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia, Elective Surgery
- What is being tested?
- Rocuronium Bromide (Pretreatment Injection) and Rocuronium Bromide (Conventional Injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2026to 30 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged from 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status classification Ⅰ, Ⅱ or Ⅲ
- Elective surgery requiring general anesthesia with tracheal intubation
- Able to understand the study and voluntarily sign written informed consent
- Male or female, no gender restriction
Who cannot join
- Severe hepatic dysfunction (ALT/AST > 3 times the upper limit of normal) or renal dysfunction (creatinine > 2 times the upper limit of normal)
- Central nervous system diseases or severe neuromuscular disorders
- Severe arrhythmia or cardiac dysfunction (NYHA class Ⅲ-Ⅳ, or ejection fraction EF < 30%)
- Known hypersensitivity or allergy to rocuronium, midazolam, propofol or other study-related drugs
- Refusal to participate in this clinical trial
- Pregnant or breastfeeding women
- History of predicted difficult airway requiring awake tracheal intubation
- Contraindications to rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, prospective, randomized, controlled trial comparing pre-injection versus standard bolus administration of rocuronium bromide for general anesthesia induction. A total of 108 adult patients (18-65 years, ASA I-III) scheduled for elective surgery requiring endotracheal intubation will be enrolled and randomized 1:1 to either the pre-injection group or control group.
The pre-injection group will receive rocuronium 0.06 mg/kg as a priming dose followed by 0.54 mg/kg 3 minutes later. The control group will receive rocuronium 0.6 mg/kg as a single bolus. All patients will receive standardized anesthesia induction with midazolam and propofol.
Read more
The primary outcome is neuromuscular blockade onset time (seconds). Secondary outcomes include hemodynamic parameters (SBP, DBP, MAP, HR, CO, SV, SVR), injection pain incidence, and adverse events.
This study aims to investigate whether pre-injection of rocuronium can shorten neuromuscular blockade onset time while maintaining hemodynamic stability compared to standard bolus administration.
- Conditions
- General Anesthesia, Elective Surgery
- Being tested
- Rocuronium Bromide (Pretreatment Injection), Rocuronium Bromide (Conventional Injection)
- Keywords
- Rocuronium bromide, Onset time, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium Bromide (Pretreatment Injection)Drug
Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
Rocuronium Bromide (Conventional Injection)Drug
Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Pretreated Rocuronium Group | Experimental | Not described Receives: Drug: Rocuronium Bromide (Pretreatment Injection) |
| Conventional Administration Group | Active comparator | Not described Receives: Drug: Rocuronium Bromide (Conventional Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular blockade onset time
The time interval from injection of rocuronium bromide to maximum neuromuscular block effect
Measured: Within 5 minutes after completion of rocuronium-bromide injection
Secondary outcomes (10)
Systolic Blood Pressure (SBP)
Measured: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Diastolic Blood Pressure (DBP)
Measured: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Mean Arterial Pressure (MAP)
Measured: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Heart Rate (HR)
Measured: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Cardiac Output (CO)
Measurement instrument: Non-invasive continuous blood pressure and cardiac output monitoring system (Model T20A).
Measurement method: Finger cuff volume pulse wave plethysmography, the device automatically calculates real-time CO value, unit: L/min.
Assessment method: Record stable CO value after waveform stabilization for 10 seconds at each time point; compare absolute value and percentage change vs baseline to evaluate the hemodynamic effect of rocuronium.
Measured: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Stroke Volume (SV)
Measurement instrument: Non-invasive continuous blood pressure and cardiac output monitoring system (Model T20A).
Measurement method: Continuous finger pulse wave monitoring, automatic calculation of stroke volume (unit: mL/beat).
Assessment method: Record stable SV readings at each time point and analyze dynamic changes compared with baseline.
Measured: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Systemic Vascular Resistance (SVR)
Measurement device: Non-invasive continuous blood pressure and cardiac output monitor (Model T20A).
Measurement method: SVR (unit: dyn·s·cm-⁵) is automatically calculated by the monitor using real-time mean arterial pressure, central venous pressure and cardiac output.
Assessment: SVR values were recorded once readings stabilized to assess changes in total peripheral vascular resistance after rocuronium administration.
Measured: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Injection Pain
Four-point grading scale for evaluating limb withdrawal reaction induced by injection pain:
0 = No limb contraction or twitching;
- = Only slight wrist movement, no movement of other arm joints;
- = Entire arm movement/withdrawal involving elbow, shoulder and other joints;
- = Systemic response with movements across multiple limbs beyond one single limb.
Subjects with a score ≥1 are defined as having injection pain.
Measured: Pain assessment is performed within 5 minutes after completion of rocuronium injection.
Limb Withdrawal Response
Four-point grading scale for evaluating limb withdrawal reaction induced by injection pain:
0 = No limb contraction or twitching;
- = Only slight wrist movement, no movement of other arm joints;
- = Entire arm movement/withdrawal involving elbow, shoulder and other joints;
- = Systemic response with movements across multiple limbs beyond one single limb.
Subjects with a score ≥1 are defined as having injection pain.
Measured: Assessment shall be completed within 5 minutes after rocuronium injection.
Adverse Events
Record adverse events occurring during perioperative period, including severe bradycardia (heart rate <45 beats per minute), hypotension (mean arterial pressure MAP <65 mmHg), various arrhythmias and allergic reactions. The number and incidence of each type of adverse event will be counted.
Assessment method: Vital signs are continuously monitored intraoperatively. Anesthesiologists identify and record all eligible adverse events in real time, with documentation of onset time, duration and corresponding interventions.
Measured: Continuous assessment from the start of anesthesia induction until the end of surgery; the maximum assessment period is the perioperative period of a single operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start4 Jul 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716891
- Sponsor's protocol ID
- KYLL-2026-0131
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-injection of Rocuronium on Neuromuscular Blockade Onset Time and Hemodynamics During General Anesthesia Induction
- ClinicalTrials.gov ID
- NCT07716891
- Acronym / sponsor ID
- KYLL-2026-0131
- Conditions
- General Anesthesia, Elective Surgery
- Keywords
- Rocuronium bromide, Onset time, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 4 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 21 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 is a single-center, prospective, randomized, controlled trial comparing pre-injection versus standard bolus administration of rocuronium bromide for general anesthesia induction. A total of 108 adult patients (18-65 years, ASA I-III) scheduled for elective surgery requiring endotracheal intubation will be enrolled and randomized 1:1 to either the pre-injection group or control group.
The pre-injection group will receive rocuronium 0.06 mg/kg as a priming dose followed by 0.54 mg/kg 3 minutes later. The control group will receive rocuronium 0.6 mg/kg as a single bolus. All patients will receive standardized anesthesia induction with midazolam and propofol.
The primary outcome is neuromuscular blockade onset time (seconds). Secondary outcomes include hemodynamic parameters (SBP, DBP, MAP, HR, CO, SV, SVR), injection pain incidence, and adverse events.
This study aims to investigate whether pre-injection of rocuronium can shorten neuromuscular blockade onset time while maintaining hemodynamic stability compared to standard bolus administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pretreated Rocuronium Group | Experimental | Drug: Rocuronium Bromide (Pretreatment Injection) |
| Conventional Administration Group | Active comparator | Drug: Rocuronium Bromide (Conventional Injection) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status classification Ⅰ, Ⅱ or Ⅲ
- Elective surgery requiring general anesthesia with tracheal intubation
- Able to understand the study and voluntarily sign written informed consent
- Male or female, no gender restriction
Key exclusion criteria (8 listed)
- Severe hepatic dysfunction (ALT/AST > 3 times the upper limit of normal) or renal dysfunction (creatinine > 2 times the upper limit of normal)
- Central nervous system diseases or severe neuromuscular disorders
- Severe arrhythmia or cardiac dysfunction (NYHA class Ⅲ-Ⅳ, or ejection fraction EF < 30%)
- Known hypersensitivity or allergy to rocuronium, midazolam, propofol or other study-related drugs
- Refusal to participate in this clinical trial
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 |
|---|---|---|
| Rocuronium Bromide (Pretreatment Injection)Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction | Drug | Pretreated Rocuronium Group |
| Rocuronium Bromide (Conventional Injection)Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction | Drug | Conventional Administration Group |
Primary outcome
Neuromuscular blockade onset time
Time frame: Within 5 minutes after completion of rocuronium-bromide injection
The time interval from injection of rocuronium bromide to maximum neuromuscular block effect
10 secondary outcomes
Systolic Blood Pressure (SBP)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Diastolic Blood Pressure (DBP)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Mean Arterial Pressure (MAP)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Heart Rate (HR)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Cardiac Output (CO)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Stroke Volume (SV)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Systemic Vascular Resistance (SVR)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Injection Pain
Time frame: Pain assessment is performed within 5 minutes after completion of rocuronium injection.
Limb Withdrawal Response
Time frame: Assessment shall be completed within 5 minutes after rocuronium injection.
Adverse Events
Time frame: Continuous assessment from the start of anesthesia induction until the end of surgery; the maximum assessment period is the perioperative period of a single operation.
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium Bromide (Pretreatment Injection) and Rocuronium Bromide (Conventional Injection) in people with General Anesthesia and Elective Surgery, run by General Hospital of Ningxia Medical 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 5 inclusion and 8 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 2 Oct 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?
Neuromuscular blockade onset time (time frame: Within 5 minutes after completion of rocuronium-bromide injection). 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 2 Oct 2026.