Nondepolarising Muscle RelaxantsNCT05716256
Effect of Ulinastatin on the Action of NDMRs (Rocuronium / Cisatracurium)
A study testing Ulinastatin in people with Nondepolarising Muscle Relaxants, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The aim of this research was to determine the influence of ulinastatin on nondepolarising muscle relaxants Rocuronium and Cisatracurium. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Nondepolarising Muscle Relaxants
- What is being tested?
- Ulinastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 25 Jun 2023
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergo elective pancreaticoduodenectomy surgery
- Age ranging from 25 to 60 years，body mass index (BMI)18-24kg/m2, American Society of Anesthesiologists (ASA) grades 1 or 2.
- Receive general anesthesia and muscle relaxants intraoperatively.
Who cannot join
- patients ASA class 3 and above
- Severe cardiac or respiratory diseases, liver( Child-Pugh class B or C ) or kidney disease( estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m²)
- Pregnant women.
- Patients with neurological dysfunction including myasthenia gravis, epilepsy or psychiatric disorders
- Patients on any premedications including antisialagogues .
- Patients on drugs known to interfere with neuromuscular transmission including but not exclusive to anticonvulsants, calcium channel blockers, β-blockers, corticosteroids, diuretics and antibiotics of the aminoglycoside group
Show all 9Show fewer
- Patients known allergy to propofol and sufentanil or remifentanil,
- emergency operations.
- Patients judged by the investigator to be unsuitable for participation in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Effect of Ulinastatin on the Action of Nondepolarising Muscle Relaxants Rocuronium / Cisatracurium
The aim of this research was to determine the influence of ulinastatin on nondepolarising muscle relaxants Rocuronium and Cisatracurium.
Read the detailed description
BACKGROUND: Ulinastatin is a protease inhibitor derived from human urine. The effects of ulinastatin on muscle relaxants have been attributed to its capacity to cause an increase in liver circulation, diuresis and possibly increased acetylcholine release. Rocuronium is mainly eliminated via the liver and kidneys, whereas cisatracurium is mainly cleared via Hofmann elimination, which is organ-independent. The effects of ulinastatin on cisatracurium have not been assessed before. Moreover, the effects of ulinastatin on the recovery period of rocuronium have not been adequately studied before. In this study, the effects of ulinastatin on cisatracurium are compared with the effects of ulinastatin on rocuronium. This is done by contrasting the ulinastatin-induced changes in onset time, clinical duration, and recovery duration for rocuronium with those for cisatracurium.
METHODS: 120 patients will be enrolled in this study and assigned randomly into 4 equal groups using a computer-generated randomization sequence:
ROC-ULI Group: Ulinastatin (5000 U/kg) administered 2 minutes prior to rocuronium (0.6 mg/kg) ROC-NS Group (Control): Normal saline (0.1 mL/kg) administered 2 minutes prior to rocuronium (0.6 mg/kg) CIS-ULI Group: Ulinastatin (5000 U/kg) administered 2 minutes prior to cisatracurium (0.1 mg/kg) CIS-NS Group (Control): Normal saline (0.1 mL/kg) administered 2 minutes prior to cisatracurium (0.1 mg/kg) Acceleromyography using response to TOF (train of four) stimulation is used to assess neuromuscular function. The site of stimulation and response assessment are the ulnar nerve and the adductor pollicis muscle respectively. The primary outcome measure is clinical duration (Dur-25%), defined as the time interval from the end of injection of the neuromuscular blocking agent until recovery of T1 to 25% of baseline.
Secondary outcomes include: the onset time, the times to return of the first, second, third, and fourth response to TOF stimulation (RT1, RT2, RT3, and RT4 respectively), the duration of moderate neuromuscular block (RT1-RT4), the duration 50%, the recovery TOF 0.7 period, and the duration TOF 0.7. Anesthesia is induced and maintained with propofol using target-controlled infusion. p < 0.05 is considered statistically significant. Analgesia is achieved with an initial bolus of sufentanil followed by remifentanil infusion. Depth of anesthesia is monitored using the Narcotrend™ index.
Statistical Analysis: Sample size calculation was based on the primary outcome, the clinical duration of neuromuscular blockade (Dur-25%). Because no previous study had investigated the effect of ulinastatin on cisatracurium, the estimation was derived from the study by Kim et al. evaluating rocuronium-induced neuromuscular blockade. A mean difference of 5 minutes with a standard deviation of 4.5 minutes was assumed. A minimum of 16 patients per group was required to achieve 90% power with a two-sided α of 0.05. To enhance the robustness of the analysis, 30 patients will be enrolled in each group (120 patients in total).Continuous data will be assessed for normality via Shapiro-Wilk test and expressed as mean ± SD or median (IQR) . Inter-group comparisons will be performed using one-way ANOVA , Kruskal-Wallis , or chi-square tests as appropriate. Longitudinal outcomes will be evaluated using a linear mixed-effects model , incorporating a participant-specific random intercept and fixed effects for group, categorical time, and their interaction . Continuous data will be standardized to facilitate model convergence . All tests are two-sided with P < 0.05 considered significant.
- Conditions
- Nondepolarising Muscle Relaxants
- Being tested
- Ulinastatin, Placebo Comparator (0.9% NaCl)
- Keywords
- Ulinastatin, Rocuronium, Cisatracurium, Train of four (TOF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
The ulinastatin groups received ulinastatin 5000U/kg two minutes before the administration of muscle relaxants
Placebo Comparator (0.9% NaCl)Drug
The saline control groups received normal saline 0.1ml/kg two minutes before the administration of muscle relaxants
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium | Experimental | The Rocuronium groups received ulinastatin 5000U/kg or saline 0.1 mL/kg followed by rocuronium 0.6 mg/kg Receives: Drug: Ulinastatin; Drug: Placebo Comparator (0.9% NaCl) |
| Cisatracurium | Experimental | The Cisatracurium groups received ulinastatin 5000U/kg or normal saline 0.1 ml/kg followed by cisatracurium 0.1 mg/kg Receives: Drug: Ulinastatin; Drug: Placebo Comparator (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration 25%
Duration 25% defined as the time from start of injection of neuromuscular blocker to T1 recovery to 25%.
Measured: All measurements were performed before the creation of pneumoperitoneum
Secondary outcomes (9)
Onset time
Onset time is defined as the period from the start of neuromuscular blocker injection to the time point at which T1 has decreased to 5% of its initial control value.
Measured: All measurements were performed before the creation of pneumoperitoneum
RT1
RT1 is defined as the time from the start of injection of the neuromuscular blocker to the reappearance of T1
Measured: All measurements were performed before the creation of pneumoperitoneum
RT2
RT2 is defined as the time from the start of injection of the neuromuscular blocker to the reappearance of T2
Measured: All measurements were performed before the creation of pneumoperitoneum
RT3
RT3 is defined as the time from the start of injection of the neuromuscular blocker to the reappearance of T3
Measured: All measurements were performed before the creation of pneumoperitoneum
RT4
RT4 is defined as the time from the start of injection of the neuromuscular blocker to the reappearance of T4
Measured: All measurements were performed before the creation of pneumoperitoneum
RT1-RT4
RT1-RT4 defined as the duration of moderate neuromuscular block, was calculated as the interval between RT1 and RT4
Measured: All measurements were performed before the creation of pneumoperitoneum
Dur-50%
Dur-50% is defined as the time interval from the end of injection of the neuromuscular blocking agent until the first twitch height returns to 50% of its baseline control value
Measured: All measurements were performed before the creation of pneumoperitoneum
Dur-TOF 0.7
Duration TOF 0.7 (Dur-TOF 0.7) was defined as the time from the end of neuromuscular blocker injection to the recovery of TOF ratio to 0.7.
Measured: All measurements were performed before the creation of pneumoperitoneum
Rec-TOF 0.7
The recovery period to TOF 0.7 (Rec-TOF 0.7) was defined as the time from the reappearance of T4 until the TOF ratio recovered to 0.7
Measured: All measurements were performed before the creation of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Feb 2023
- Primary completion15 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nondepolarising Muscle RelaxantsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai Ling, Huazhong University of Science and Technology
- Investigators
- Xu Hui, Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716256
- Sponsor's protocol ID
- TJ-IRB20221241
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ulinastatin on the Action of Nondepolarising Muscle Relaxants Rocuronium / Cisatracurium
- ClinicalTrials.gov ID
- NCT05716256
- Acronym / sponsor ID
- TJ-IRB20221241
- Conditions
- Nondepolarising Muscle Relaxants
- Keywords
- Ulinastatin, Rocuronium, Cisatracurium, Train of four (TOF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 8 Feb 2023 (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.
The aim of this research was to determine the influence of ulinastatin on nondepolarising muscle relaxants Rocuronium and Cisatracurium.
Detailed description
BACKGROUND: Ulinastatin is a protease inhibitor derived from human urine. The effects of ulinastatin on muscle relaxants have been attributed to its capacity to cause an increase in liver circulation, diuresis and possibly increased acetylcholine release. Rocuronium is mainly eliminated via the liver and kidneys, whereas cisatracurium is mainly cleared via Hofmann elimination, which is organ-independent. The effects of ulinastatin on cisatracurium have not been assessed before. Moreover, the effects of ulinastatin on the recovery period of rocuronium have not been adequately studied before. In this study, the effects of ulinastatin on cisatracurium are compared with the effects of ulinastatin on rocuronium. This is done by contrasting the ulinastatin-induced changes in onset time, clinical duration, and recovery duration for rocuronium with those for cisatracurium.
METHODS: 120 patients will be enrolled in this study and assigned randomly into 4 equal groups using a computer-generated randomization sequence:
ROC-ULI Group: Ulinastatin (5000 U/kg) administered 2 minutes prior to rocuronium (0.6 mg/kg) ROC-NS Group (Control): Normal saline (0.1 mL/kg) administered 2 minutes prior to rocuronium (0.6 mg/kg) CIS-ULI Group: Ulinastatin (5000 U/kg) administered 2 minutes prior to cisatracurium (0.1 mg/kg) CIS-NS Group (Control): Normal saline (0.1 mL/kg) administered 2 minutes prior to cisatracurium (0.1 mg/kg) Acceleromyography using response to TOF (train of four) stimulation is used to assess neuromuscular function. The site of stimulation and response assessment are the ulnar nerve and the adductor pollicis muscle respectively. The primary outcome measure is clinical duration (Dur-25%), defined as the time interval from the end of injection of the neuromuscular blocking agent until recovery of T1 to 25% of baseline.
Secondary outcomes include: the onset time, the times to return of the first, second, third, and fourth response to TOF stimulation (RT1, RT2, RT3, and RT4 respectively), the duration of moderate neuromuscular block (RT1-RT4), the duration 50%, the recovery TOF 0.7 period, and the duration TOF 0.7. Anesthesia is induced and maintained with propofol using target-controlled infusion. p < 0.05 is considered statistically significant. Analgesia is achieved with an initial bolus of sufentanil followed by remifentanil infusion. Depth of anesthesia is monitored using the Narcotrend™ index.
Statistical Analysis: Sample size calculation was based on the primary outcome, the clinical duration of neuromuscular blockade (Dur-25%). Because no previous study had investigated the effect of ulinastatin on cisatracurium, the estimation was derived from the study by Kim et al. evaluating rocuronium-induced neuromuscular blockade. A mean difference of 5 minutes with a standard deviation of 4.5 minutes was assumed. A minimum of 16 patients per group was required to achieve 90% power with a two-sided α of 0.05. To enhance the robustness of the analysis, 30 patients will be enrolled in each group (120 patients in total).Continuous data will be assessed for normality via Shapiro-Wilk test and expressed as mean ± SD or median (IQR) . Inter-group comparisons will be performed using one-way ANOVA , Kruskal-Wallis , or chi-square tests as appropriate. Longitudinal outcomes will be evaluated using a linear mixed-effects model , incorporating a participant-specific random intercept and fixed effects for group, categorical time, and their interaction . Continuous data will be standardized to facilitate model convergence . All tests are two-sided with P < 0.05 considered significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | Experimental | Drug: Ulinastatin, Drug: Placebo Comparator (0.9% NaCl)The Rocuronium groups received ulinastatin 5000U/kg or saline 0.1 mL/kg followed by rocuronium 0.6 mg/kg |
| Cisatracurium | Experimental | Drug: Ulinastatin, Drug: Placebo Comparator (0.9% NaCl)The Cisatracurium groups received ulinastatin 5000U/kg or normal saline 0.1 ml/kg followed by cisatracurium 0.1 mg/kg |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergo elective pancreaticoduodenectomy surgery
- Age ranging from 25 to 60 years，body mass index (BMI)18-24kg/m2, American Society of Anesthesiologists (ASA) grades 1 or 2.
- Receive general anesthesia and muscle relaxants intraoperatively.
Key exclusion criteria (9 listed)
- patients ASA class 3 and above
- Severe cardiac or respiratory diseases, liver( Child-Pugh class B or C ) or kidney disease( estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m²)
- Pregnant women.
- Patients with neurological dysfunction including myasthenia gravis, epilepsy or psychiatric disorders
- Patients on any premedications including antisialagogues .
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 |
|---|---|---|
| UlinastatinThe ulinastatin groups received ulinastatin 5000U/kg two minutes before the administration of muscle relaxants | Drug | Cisatracurium, Rocuronium |
| Placebo Comparator (0.9% NaCl)The saline control groups received normal saline 0.1ml/kg two minutes before the administration of muscle relaxants | Drug | Cisatracurium, Rocuronium |
Primary outcome
Duration 25%
Time frame: All measurements were performed before the creation of pneumoperitoneum
Duration 25% defined as the time from start of injection of neuromuscular blocker to T1 recovery to 25%.
9 secondary outcomes
Onset time
Time frame: All measurements were performed before the creation of pneumoperitoneum
RT1
Time frame: All measurements were performed before the creation of pneumoperitoneum
RT2
Time frame: All measurements were performed before the creation of pneumoperitoneum
RT3
Time frame: All measurements were performed before the creation of pneumoperitoneum
RT4
Time frame: All measurements were performed before the creation of pneumoperitoneum
RT1-RT4
Time frame: All measurements were performed before the creation of pneumoperitoneum
Dur-50%
Time frame: All measurements were performed before the creation of pneumoperitoneum
Dur-TOF 0.7
Time frame: All measurements were performed before the creation of pneumoperitoneum
Rec-TOF 0.7
Time frame: All measurements were performed before the creation of pneumoperitoneum
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 8 Jul 2026.
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.
Xu Hui study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulinastatin in people with Nondepolarising Muscle Relaxants, run by Huazhong University of Science and Technology 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 3 inclusion and 9 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 8 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?
Duration 25% (time frame: All measurements were performed before the creation of pneumoperitoneum). 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 8 Jul 2026.