Anesthesia, GeneralNCT06150001
Reduction of Rocuronium-induced Injection Pain With Aspiration of Blood
A study testing rocuronium-normal-saline mixture, rocuronium-lidocaine mixture and rocuronium-blood mixture in people with Anesthesia, General, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn about reduction of rocuronium injection pain in participants receiving general anesthesia. The main question aims to answer is whether diluting rocuronium with blood can reduce rocuronium injection pain. Rocuronium is a rapid onset muscle relaxant used in general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- rocuronium-normal-saline mixture, rocuronium-lidocaine mixture and rocuronium-blood mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2023to 31 Jul 2024
- 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
- Willing to sign the written informed consent form.
- Males and females aged 18 to 65.
- Undergoing endotracheal intubation under general anesthesia.
- Anesthesia physical status classification II or below.
Who cannot join
- estimated glomerular filtration rate less than 60
- History of cirrhosis or liver failure
- Neuromuscular disease or neurological symptoms
- Mental illness
- Arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn about reduction of rocuronium injection pain in participants receiving general anesthesia. The main question aims to answer is whether diluting rocuronium with blood can reduce rocuronium injection pain. Rocuronium is a rapid onset muscle relaxant used in general anesthesia. Lidocaine is a local anesthetic. Researchers will
- inject diluted rocuronium in participant's intravenous catheter during induction. • record withdrawal movement and rocuronium onset time and duration measured by train-of-four (TOF).
Researchers will compare between rocuronium diluted with blood, lidocaine and normal saline to see if blood can reduce rocuronium injection pain.
Read the detailed description
This clinical trial uses a random table for sequential randomization, randomly assigning subjects to 3 groups, each consisting of 40 participants.
Researcher will confirm the patency of peripheral intravenous lines before induction. If peripheral intravenous lines cannot be used, they will be readministered at another injection site. If there are difficulties in peripheral intravenous injection, the participant will need to withdraw from this clinical trial. The neuromuscular monitoring device (NMT) is installed before the start of the clinical trial to monitor the effects of the drug. To avoid influencing the final results, fentanyl and 2%lidocaine will not be administered before injecting rocuronium. Anesthesia induction begins with the administration of oxygen through a mask to assist breathing. Initially, propofol is injected at a dose of 1.5 to 2mg/kg. Once the participant is confirmed to have lost consciousness, researchers will inject diluted rocuronium immediately, with an injection speed of 10 to 15 seconds. The dose of rocuronium for each participant is 0.8 mg/kg. The first group is pre-diluted with 2mL of normal saline, the second group with 2mL of 2%lidocaine, and the third group with 2mL of the participant's blood. To avoid clotting of blood, the procedure of the third group involves using a syringe containing rocuronium to withdraw 2mL of blood from the vein, followed by simultaneous injection into the intravenous line. The NMT is used to monitor the drug's effects, defining the onset time as the time from rocuronium injection to the disappearance of train-of-four (TOF) count T1 and the duration of action as the time from rocuronium injection to the appearance of TOF count T1.
- Conditions
- Anesthesia, General
- Being tested
- rocuronium-normal-saline mixture, rocuronium-lidocaine mixture, rocuronium-blood mixture
- Keywords
- rocuronium, injection pain, withdrawal movement, rocuronium injection pain, rocuronium withdrawal movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rocuronium-normal-saline mixtureDrug
Also called rocuronium
rocuronium will be pre-diluted with 2mL of normal saline. Researchers will inject the mixture into intravenous catheter.
rocuronium-lidocaine mixtureDrug
Also called rocuronium
rocuronium will be pre-diluted with 2mL of 2%lidocaine. Researchers will inject the mixture into intravenous catheter.
rocuronium-blood mixtureDrug
Also called rocuronium
Researchers will connect a syringe which contains 0.8mg/kg of rocuronium intravenous catheter, and then withdraw blood into the syringe. Finally inject the mixture into intravenous catheter.
| Study group | Role | What they receive |
|---|---|---|
| dilute with normal saline | Placebo comparator | Researchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of normal saline. The rocuronium mixture will be injected into participants intravenous catheter. Receives: Drug: rocuronium-normal-saline mixture |
| dilute with 2%lidocaine | Active comparator | Researchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of 2%lidocaine. The rocuronium mixture will be injected into participants intravenous catheter. Receives: Drug: rocuronium-lidocaine mixture |
| dilute with investigator's blood | Experimental | Researchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of blood. The rocuronium mixture will be injected into participants intravenous catheter. Receives: Drug: rocuronium-blood mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
withdrawal movement by 4-point-scale
withdrawal movement is measured by 4-point-scale. Zero is equivalent to no withdrawal movement. One is equivalent to withdrawal movement involving wrist joint. Two is equivalent to withdrawal movement involving elbow joint. Three is equivalent to withdrawal movement involving shoulder joint
Measured: From enrollment to the end of assessment at thirty minutes.
Secondary outcomes (2)
onset time
onset time is defined by injection of rocuronium mixture to the disappearance of Train-of-four count T1.
Measured: From enrollment to the end of assessment at 3 minutes.
duration of action
Duration of action is defined by injection of rocuronium mixture to appearance of Train-of-four count T1.
Measured: From enrollment to the end of assessment at one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150001
- Sponsor's protocol ID
- 202301309A3
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Rocuronium-induced Injection Pain With Aspiration of Blood
- ClinicalTrials.gov ID
- NCT06150001
- Acronym / sponsor ID
- 202301309A3
- Conditions
- Anesthesia, General
- Keywords
- rocuronium, injection pain, withdrawal movement, rocuronium injection pain, rocuronium withdrawal movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 29 Nov 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 goal of this clinical trial is to learn about reduction of rocuronium injection pain in participants receiving general anesthesia. The main question aims to answer is whether diluting rocuronium with blood can reduce rocuronium injection pain. Rocuronium is a rapid onset muscle relaxant used in general anesthesia. Lidocaine is a local anesthetic. Researchers will
- inject diluted rocuronium in participant's intravenous catheter during induction. • record withdrawal movement and rocuronium onset time and duration measured by train-of-four (TOF).
Researchers will compare between rocuronium diluted with blood, lidocaine and normal saline to see if blood can reduce rocuronium injection pain.
Detailed description
This clinical trial uses a random table for sequential randomization, randomly assigning subjects to 3 groups, each consisting of 40 participants.
Researcher will confirm the patency of peripheral intravenous lines before induction. If peripheral intravenous lines cannot be used, they will be readministered at another injection site. If there are difficulties in peripheral intravenous injection, the participant will need to withdraw from this clinical trial. The neuromuscular monitoring device (NMT) is installed before the start of the clinical trial to monitor the effects of the drug. To avoid influencing the final results, fentanyl and 2%lidocaine will not be administered before injecting rocuronium. Anesthesia induction begins with the administration of oxygen through a mask to assist breathing. Initially, propofol is injected at a dose of 1.5 to 2mg/kg. Once the participant is confirmed to have lost consciousness, researchers will inject diluted rocuronium immediately, with an injection speed of 10 to 15 seconds. The dose of rocuronium for each participant is 0.8 mg/kg. The first group is pre-diluted with 2mL of normal saline, the second group with 2mL of 2%lidocaine, and the third group with 2mL of the participant's blood. To avoid clotting of blood, the procedure of the third group involves using a syringe containing rocuronium to withdraw 2mL of blood from the vein, followed by simultaneous injection into the intravenous line. The NMT is used to monitor the drug's effects, defining the onset time as the time from rocuronium injection to the disappearance of train-of-four (TOF) count T1 and the duration of action as the time from rocuronium injection to the appearance of TOF count T1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dilute with normal saline | Placebo comparator | Drug: rocuronium-normal-saline mixtureResearchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of normal saline. The rocuronium mixture will be injected into participants intravenous catheter. |
| dilute with 2%lidocaine | Active comparator | Drug: rocuronium-lidocaine mixtureResearchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of 2%lidocaine. The rocuronium mixture will be injected into participants intravenous catheter. |
| dilute with investigator's blood | Experimental | Drug: rocuronium-blood mixtureResearchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of blood. The rocuronium mixture will be injected into participants intravenous catheter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to sign the written informed consent form.
- Males and females aged 18 to 65.
- Undergoing endotracheal intubation under general anesthesia.
- Anesthesia physical status classification II or below.
Key exclusion criteria (5 listed)
- estimated glomerular filtration rate less than 60
- History of cirrhosis or liver failure
- Neuromuscular disease or neurological symptoms
- Mental illness
- Arrhythmia
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-normal-saline mixtureAlso: rocuroniumrocuronium will be pre-diluted with 2mL of normal saline. Researchers will inject the mixture into intravenous catheter. | Drug | dilute with normal saline |
| rocuronium-lidocaine mixtureAlso: rocuroniumrocuronium will be pre-diluted with 2mL of 2%lidocaine. Researchers will inject the mixture into intravenous catheter. | Drug | dilute with 2%lidocaine |
| rocuronium-blood mixtureAlso: rocuroniumResearchers will connect a syringe which contains 0.8mg/kg of rocuronium intravenous catheter, and then withdraw blood into the syringe. Finally inject the mixture into intravenous catheter. | Drug | dilute with investigator's blood |
Primary outcome
withdrawal movement by 4-point-scale
Time frame: From enrollment to the end of assessment at thirty minutes.
withdrawal movement is measured by 4-point-scale. Zero is equivalent to no withdrawal movement. One is equivalent to withdrawal movement involving wrist joint. Two is equivalent to withdrawal movement involving elbow joint. Three is equivalent to withdrawal movement involving shoulder joint
2 secondary outcomes
onset time
Time frame: From enrollment to the end of assessment at 3 minutes.
duration of action
Time frame: From enrollment to the end of assessment at one hour.
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 22 Aug 2024.
- Individual participant dataSharing planned: No
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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-normal-saline mixture, rocuronium-lidocaine mixture and rocuronium-blood mixture in people with Anesthesia, General, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 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 22 Aug 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
withdrawal movement by 4-point-scale (time frame: From enrollment to the end of assessment at thirty minutes.). 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 22 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.