Rocuronium Adverse ReactionNCT06865300
Effects of Pretreatment With Different Doses of Lidocaine on Injection Pain
A study testing Lidocain 40 mg, lidocain 1 mg/kg and serum physiologic in people with Rocuronium Adverse Reaction and Lidocaine Adverse Reaction, run by Giresun University at 2 sites in Turkey (Türkiye).
Trial summary
One of the medications administered to patients in general anesthesia practice is rocuronium, which causes pain during intravenous administration. It is known that a drug containing lidocaine as the active ingredient can reduce the pain caused by rocuronium in different doses. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rocuronium Adverse Reaction, Lidocaine Adverse Reaction
- What is being tested?
- Lidocain 40 mg, lidocain 1 mg/kg and serum physiologic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 31 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients aged between 18 and 65 with ASA I and II
Who cannot join
- Chronic sedative anxiolytic use
- Those with ASA III and higher
- Patients under 18 and over 65 years of age
- Those with severe COPD, asthma, or reactive airway disease
- Patients with a history of neuropsychiatric or neurological diseases
- Those with infections on the back of the hand
Show all 11Show fewer
- Pregnant women
- Patients who will undergo rapid induction
- Patients with liver and kidney dysfunction
- Those with a history of thrombophlebitis
- Patients with muscle diseases
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Giresun University
Giresun, Turkey
Giresun Training and Research Hospital
Giresun
About this study
Official title: Effects of Pretreatment With Different Doses of Lidocaine on Injection Pain and Rocuronium-induced Withdrawal Response
One of the medications administered to patients in general anesthesia practice is rocuronium, which causes pain during intravenous administration. It is known that a drug containing lidocaine as the active ingredient can reduce the pain caused by rocuronium in different doses. The effective dose of lidocaine remains a topic of debate. In our study, we aimed to investigate the efficacy of two different doses of lidocaine. No adverse effects are expected from this medication.
Read the detailed description
The patients were randomly divided into three groups by a simple drawing-lots method: control group (Group C), 40 mg lidocaine group (Group L) and 1 mg/kg lidocaine group (Group L1). All patients were taken to the operating room without premedication and standard monitoring was applied. A 20 G intravenous catheter was inserted on the dorsum of the patients' non-dominant hand, and 100 ml/hour of physiological saline solution was infused over a 5-minute period. After randomization, 5 ml of isotonic solution was administered to the control group, 40 mg of lidocaine to the L group, and 1 mg kg-1 of lidocaine intravenously to the L1 group. Patients were administered 0.06 mg/kg of rocuronium, and they were asked, "Do you feel any pain or discomfort in your arm?" The pain intensity expressed by the patient was evaluated and recorded using the 5-point pain scale. After induction and intubation, the patients' blood pressure, pulse, and saturation values were recorded.
- Being tested
- Lidocain 40 mg, lidocain 1 mg/kg, serum physiologic
- Keywords
- rocuronium, lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocain 40 mgDrug
Also called Lidocain, 40 mg lidocain
We injected 40 mg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale.
lidocain 1 mg/kgDrug
Also called lidocain, 1 mg/kg lidocain
We injected 1 mg/kg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale.
serum physiologicDrug
Also called izotonic fluid
We injected serum physiologic before rocuronium injection. Then we recorded pain score by using visual analog scale.
| Study group | Role | What they receive |
|---|---|---|
| Injection of serum physiologic that contains no drug. | Placebo comparator | We injected serum physiologic that contains no drug before injection of rocuronium and recorded pain score. Receives: Drug: serum physiologic |
| 40 mg lidocain group | Experimental | We injected 40 mg lidocain for the prevention of injection pain caused by rocuronium. We injected 0.06 mg/kg rocurunium and recorded pain by using visual analog scale. Receives: Drug: Lidocain 40 mg |
| 1 mg/kg lidocain group | Experimental | We injected 1 mg/kg lidocain for the prevention of injection pain caused by rocuronium. We injected 0.06 mg/kg rocurunium and recorded pain score by using visual analog scale. Receives: Drug: lidocain 1 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog score after the injection
We described Visual analog scale to the patient before the day of surgery. On the visual analog scale, a score of 10 is the worst pain in life, while a score of 0 is no pain. The patient is asked to give a score to his pain caused by rocuronium injection and the score is recorded.
Measured: From enrollment to the end of injection at 5 minutes.
Secondary outcomes (4)
Changes on heart rate
All patients who will receive general anesthesia are routinely monitored with electrocardiogram, noninvazive blood pressure and oxygen saturation. We recorded heart rate as beat per minute before and after the injections during 20 minutes.
Measured: Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
Changes on noninvasive blood pressure
All patients who will receive general anesthesia are routinely monitored with electrocardiogram, noninvazive blood pressure and oxygen saturation. We recorded noninvasive blood pressure as mmHg before and after the injections during 20 minutes.
Measured: Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
Changes on oxygen saturation
All patients who will receive general anesthesia are routinely monitored with electrocardiogram, noninvazive blood pressure and oxygen saturation. We recorded oxygen saturation as percentage before and after the injections during 20 minutes.
Measured: Hemodynamic parameters were recorded 5 minutes intervals.
Adverse effects
After the injection of the drug we observed any side effect such as metallic taste, erythema, swelling, itching, allergic reaction.
Measured: Adverse effects of the drug were observed during 5 minutes after the injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Jul 2023
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rocuronium Adverse ReactionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azime Bulut, Giresun University
- Investigators
- Azime Bulut, Study director, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865300
- Sponsor's protocol ID
- Mücahit
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh M, Chauhan H, Rath GP, Prabhakar H, Bithal PK, Dash HH. Effect of narcotic pretreatment on pain after rocuronium injection: a randomized, double-blind controlled comparison with lidocaine. J Anesth. 2007;21(4):510-2. doi: 10.1007/s00540-007-0560-8. Epub 2007 Nov 1.
PubMed 18008122Chiarella AB, Jolly DT, Huston CM, Clanachan AS. Comparison of four strategies to reduce the pain associated with intravenous administration of rocuronium. Br J Anaesth. 2003 Mar;90(3):377-9. doi: 10.1093/bja/aeg054.
PubMed 12594153Ergil J, Kavak Akelma F, Ozkan D, Bumin Aydin G, Gurel A, Akinci M. Effects of pretreatment with esmolol and lidocaine on injection pain and rocuronium-induced withdrawal response. Turk J Med Sci. 2015;45(4):959-63. doi: 10.3906/sag-1311-79.
PubMed 26422874Ahmad N, Choy CY, Aris EA, Balan S. Preventing the withdrawal response associated with rocuronium injection: a comparison of fentanyl with lidocaine. Anesth Analg. 2005 Apr;100(4):987-990. doi: 10.1213/01.ANE.0000147790.76114.3A.
PubMed 15781511Cheong KF, Wong WH. Pain on injection of rocuronium: influence of two doses of lidocaine pretreatment. Br J Anaesth. 2000 Jan;84(1):106-7. doi: 10.1093/oxfordjournals.bja.a013364.
PubMed 10740559
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pretreatment With Different Doses of Lidocaine on Injection Pain and Rocuronium-induced Withdrawal Response
- ClinicalTrials.gov ID
- NCT06865300
- Acronym / sponsor ID
- Mücahit
- Keywords
- rocuronium, lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Mar 2025 (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.
One of the medications administered to patients in general anesthesia practice is rocuronium, which causes pain during intravenous administration. It is known that a drug containing lidocaine as the active ingredient can reduce the pain caused by rocuronium in different doses. The effective dose of lidocaine remains a topic of debate. In our study, we aimed to investigate the efficacy of two different doses of lidocaine. No adverse effects are expected from this medication.
Detailed description
The patients were randomly divided into three groups by a simple drawing-lots method: control group (Group C), 40 mg lidocaine group (Group L) and 1 mg/kg lidocaine group (Group L1). All patients were taken to the operating room without premedication and standard monitoring was applied. A 20 G intravenous catheter was inserted on the dorsum of the patients' non-dominant hand, and 100 ml/hour of physiological saline solution was infused over a 5-minute period. After randomization, 5 ml of isotonic solution was administered to the control group, 40 mg of lidocaine to the L group, and 1 mg kg-1 of lidocaine intravenously to the L1 group. Patients were administered 0.06 mg/kg of rocuronium, and they were asked, "Do you feel any pain or discomfort in your arm?" The pain intensity expressed by the patient was evaluated and recorded using the 5-point pain scale. After induction and intubation, the patients' blood pressure, pulse, and saturation values were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection of serum physiologic that contains no drug. | Placebo comparator | Drug: serum physiologicWe injected serum physiologic that contains no drug before injection of rocuronium and recorded pain score. |
| 40 mg lidocain group | Experimental | Drug: Lidocain 40 mgWe injected 40 mg lidocain for the prevention of injection pain caused by rocuronium. We injected 0.06 mg/kg rocurunium and recorded pain by using visual analog scale. |
| 1 mg/kg lidocain group | Experimental | Drug: lidocain 1 mg/kgWe injected 1 mg/kg lidocain for the prevention of injection pain caused by rocuronium. We injected 0.06 mg/kg rocurunium and recorded pain score by using visual analog scale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged between 18 and 65 with ASA I and II
Key exclusion criteria (11 listed)
- Chronic sedative anxiolytic use
- Those with ASA III and higher
- Patients under 18 and over 65 years of age
- Those with severe COPD, asthma, or reactive airway disease
- Patients with a history of neuropsychiatric or neurological diseases
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 |
|---|---|---|
| Lidocain 40 mgAlso: Lidocain, 40 mg lidocainWe injected 40 mg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale. | Drug | 40 mg lidocain group |
| lidocain 1 mg/kgAlso: lidocain, 1 mg/kg lidocainWe injected 1 mg/kg lidocain before rocuronium injection. Then we recorded pain score by using visual analog scale. | Drug | 1 mg/kg lidocain group |
| serum physiologicAlso: izotonic fluidWe injected serum physiologic before rocuronium injection. Then we recorded pain score by using visual analog scale. | Drug | Injection of serum physiologic that contains no drug. |
Primary outcome
Visual analog score after the injection
Time frame: From enrollment to the end of injection at 5 minutes.
We described Visual analog scale to the patient before the day of surgery. On the visual analog scale, a score of 10 is the worst pain in life, while a score of 0 is no pain. The patient is asked to give a score to his pain caused by rocuronium injection and the score is recorded.
4 secondary outcomes
Changes on heart rate
Time frame: Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
Changes on noninvasive blood pressure
Time frame: Hemodynamic parameters were recorded 5 minutes intervals. Adverse effects of the drug were observed during 5 minutes after the injection.
Changes on oxygen saturation
Time frame: Hemodynamic parameters were recorded 5 minutes intervals.
Adverse effects
Time frame: Adverse effects of the drug were observed during 5 minutes after the injection.
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 7 Mar 2025.
- Results publication: PubMed 18008122Singh M, Chauhan H, Rath GP, Prabhakar H, Bithal PK, Dash HH. Effect of narcotic pretreatment on pain after rocuronium injection: a randomized, double-blind controlled comparison with lidocaine. J Anesth. 2007;21(4):510-2. doi: 10.1007/s00540-007-0560-8. Epub 2007 Nov 1.
- Results publication: PubMed 12594153Chiarella AB, Jolly DT, Huston CM, Clanachan AS. Comparison of four strategies to reduce the pain associated with intravenous administration of rocuronium. Br J Anaesth. 2003 Mar;90(3):377-9. doi: 10.1093/bja/aeg054.
- Results publication: PubMed 26422874Ergil J, Kavak Akelma F, Ozkan D, Bumin Aydin G, Gurel A, Akinci M. Effects of pretreatment with esmolol and lidocaine on injection pain and rocuronium-induced withdrawal response. Turk J Med Sci. 2015;45(4):959-63. doi: 10.3906/sag-1311-79.
- Results publication: PubMed 15781511Ahmad N, Choy CY, Aris EA, Balan S. Preventing the withdrawal response associated with rocuronium injection: a comparison of fentanyl with lidocaine. Anesth Analg. 2005 Apr;100(4):987-990. doi: 10.1213/01.ANE.0000147790.76114.3A.
- Results publication: PubMed 10740559Cheong KF, Wong WH. Pain on injection of rocuronium: influence of two doses of lidocaine pretreatment. Br J Anaesth. 2000 Jan;84(1):106-7. doi: 10.1093/oxfordjournals.bja.a013364.
- 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.
Azime Bulut study director
Giresun University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocain 40 mg, lidocain 1 mg/kg and serum physiologic in people with Rocuronium Adverse Reaction and Lidocaine Adverse Reaction, run by Giresun University at 2 sites in Turkey (Türkiye).
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 1 inclusion and 11 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Visual analog score after the injection (time frame: From enrollment to the end of injection at 5 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06865300, which also lists 5 linked publications.
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 7 Mar 2025.