RocuroniumNCT04236050
Continuous Infusion and Bolus Doses of Rocuronium During Lumbal Discectomy, Muscle Strength and Patient Recovery
A study testing Rocuronium in people with Rocuronium and Lumbar Discectomy, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial summary
The continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rocuronium, Lumbar Discectomy, Recovery
- What is being tested?
- Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- Dec 2015to Aug 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA ( American Society of Anesthesiologists) grading status I-III
- scheduled for lumbal discectomy under general anesthesia
- signed informed consent for participating in the research
Who cannot join
- neuromuscular disease
- poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease
- allergic reaction to any of the medications in protocol
- pregnancy
- refusal to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Continuous Infusion and Bolus Doses of Rocuronium During Anesthesia for Lumbal Discectomy on Muscle Strength and Quality of Patient Recovery
The continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.
Read the detailed description
Rocuronium is a non-depolarising neuromuscular blocking agent that can be administered in bolus doses or via continuous infusion during general anesthesia. Due to the specificity of the knee-chest position in a lumbar discectomy, many complications during anesthesia and surgery are possible. Therefore an effective and balanced intraoperative neuromuscular block is needed.
Studies so far have not included a comparison on muscle strength and quality of patient recovery of the effect of continuous infusion and bolus doses of rocuronium during anesthesia for lumbar discectomy.
The hypothesis of this research was that the continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.
The aim was to compare the influence of the continuous infusion and bolus doses of rocuronium on patient recovery. Therefore the investigators assessed how continuous infusion and bolus doses of rocuronium affect the recovery of muscle strength as measured by a hand-grip dynamometer. The quality of patient recovery was assessed by standardised questionnaire (Qor-40 - Quality of recovery questionnaire).
The aim was also to evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice.
- Conditions
- Rocuronium, Lumbar Discectomy, Recovery
- Being tested
- Rocuronium
- Keywords
- rocuronium, Qor-40, lumbar discectomy, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called general anesthesia
Rocuronium administered in continuous infusion or multiple bolus doses
| Study group | Role | What they receive |
|---|---|---|
| rocuronium is administered via continuous infusion | Experimental | 40 patients. General anesthesia is maintained with propofol and remifentanil, with standard anesthetic monitoring, bispectral index (BIS) and train-of-four(TOF). In experimental group, rocuronium was administered via continuous infusion so that theTOF ratio was 5%. Hand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.
The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery Receives: Drug: Rocuronium |
| rocuronium is administered in bolus doses | Active comparator | 40 patients. General anesthesia was maintained with propofol and remifentanil, with standard anesthetic monitoring, BIS and TOF. In this group, rocuronium was administered in separate bolus doses with the TOF ratio of 5%.
Hand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.
The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength
Change in muscle strength between groups measured my hand-grip dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.
Measured: perioperative
Change in quality of patient recovery
Change in quality of recovery between groups measured with Qor-40 questionnaire.
The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery.
Measured: up to 24 weeks
Secondary outcomes (1)
Validation of Croatian version of the quality of recovery questionnaire (Qor-40)
Translate to croatian language the quality of recovery questionnaire according to Beaton and Bullinger docrtine and evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice in croatian speaking area
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study startDec 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for RocuroniumStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Miklic Bublic, MD, PhD, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236050
- Sponsor's protocol ID
- 021
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. German.
PubMed 28573344Naguib M, Flood P, McArdle JJ, Brenner HR. Advances in neurobiology of the neuromuscular junction: implications for the anesthesiologist. Anesthesiology. 2002 Jan;96(1):202-31. doi: 10.1097/00000542-200201000-00035. No abstract available.
PubMed 11753022Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24.
PubMed 19468024Jellish WS, Brody M, Sawicki K, Slogoff S. Recovery from neuromuscular blockade after either bolus and prolonged infusions of cisatracurium or rocuronium using either isoflurane or propofol-based anesthetics. Anesth Analg. 2000 Nov;91(5):1250-5. doi: 10.1097/00000539-200011000-00037.
PubMed 11049917Sweeney BP. Neuromuscular blockade and minimal monitoring. Anaesthesia. 2010 Mar;65(3):308. doi: 10.1111/j.1365-2044.2010.06252.x. No abstract available.
PubMed 20236270Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x.
PubMed 11942873Desai A, Bekelis K, Ball PA, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Spine patient outcomes research trial: do outcomes vary across centers for surgery for lumbar disc herniation? Neurosurgery. 2012 Oct;71(4):833-42. doi: 10.1227/NEU.0b013e31826772cb.
PubMed 22791040Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.
PubMed 14576554
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Continuous Infusion and Bolus Doses of Rocuronium During Anesthesia for Lumbal Discectomy on Muscle Strength and Quality of Patient Recovery
- ClinicalTrials.gov ID
- NCT04236050
- Acronym / sponsor ID
- 021
- Conditions
- Rocuronium, Lumbar Discectomy, Recovery
- Keywords
- rocuronium, Qor-40, lumbar discectomy, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Jan 2020 (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 continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.
Detailed description
Rocuronium is a non-depolarising neuromuscular blocking agent that can be administered in bolus doses or via continuous infusion during general anesthesia. Due to the specificity of the knee-chest position in a lumbar discectomy, many complications during anesthesia and surgery are possible. Therefore an effective and balanced intraoperative neuromuscular block is needed.
Studies so far have not included a comparison on muscle strength and quality of patient recovery of the effect of continuous infusion and bolus doses of rocuronium during anesthesia for lumbar discectomy.
The hypothesis of this research was that the continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.
The aim was to compare the influence of the continuous infusion and bolus doses of rocuronium on patient recovery. Therefore the investigators assessed how continuous infusion and bolus doses of rocuronium affect the recovery of muscle strength as measured by a hand-grip dynamometer. The quality of patient recovery was assessed by standardised questionnaire (Qor-40 - Quality of recovery questionnaire).
The aim was also to evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rocuronium is administered via continuous infusion | Experimental | Drug: Rocuronium40 patients. General anesthesia is maintained with propofol and remifentanil, with standard anesthetic monitoring, bispectral index (BIS) and train-of-four(TOF). In experimental group, rocuronium was administered via continuous infusion so that theTOF ratio was 5%. Hand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia. The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery |
| rocuronium is administered in bolus doses | Active comparator | Drug: Rocuronium40 patients. General anesthesia was maintained with propofol and remifentanil, with standard anesthetic monitoring, BIS and TOF. In this group, rocuronium was administered in separate bolus doses with the TOF ratio of 5%. Hand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia. The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA ( American Society of Anesthesiologists) grading status I-III
- scheduled for lumbal discectomy under general anesthesia
- signed informed consent for participating in the research
Key exclusion criteria (5 listed)
- neuromuscular disease
- poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease
- allergic reaction to any of the medications in protocol
- pregnancy
- refusal to participate in the research
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 |
|---|---|---|
| RocuroniumAlso: general anesthesiaRocuronium administered in continuous infusion or multiple bolus doses | Drug | rocuronium is administered in bolus doses, rocuronium is administered via continuous infusion |
Primary outcome
Change in muscle strength
Time frame: perioperative
Change in muscle strength between groups measured my hand-grip dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.
Change in quality of patient recovery
Time frame: up to 24 weeks
Change in quality of recovery between groups measured with Qor-40 questionnaire. The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery.
1 secondary outcome
Validation of Croatian version of the quality of recovery questionnaire (Qor-40)
Time frame: perioperative
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 Jan 2020.
- Results publication: PubMed 28573344Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. German.
- Results publication: PubMed 11753022Naguib M, Flood P, McArdle JJ, Brenner HR. Advances in neurobiology of the neuromuscular junction: implications for the anesthesiologist. Anesthesiology. 2002 Jan;96(1):202-31. doi: 10.1097/00000542-200201000-00035. No abstract available.
- Results publication: PubMed 19468024Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24.
- Results publication: PubMed 11049917Jellish WS, Brody M, Sawicki K, Slogoff S. Recovery from neuromuscular blockade after either bolus and prolonged infusions of cisatracurium or rocuronium using either isoflurane or propofol-based anesthetics. Anesth Analg. 2000 Nov;91(5):1250-5. doi: 10.1097/00000539-200011000-00037.
- Results publication: PubMed 20236270Sweeney BP. Neuromuscular blockade and minimal monitoring. Anaesthesia. 2010 Mar;65(3):308. doi: 10.1111/j.1365-2044.2010.06252.x. No abstract available.
- Results publication: PubMed 11942873Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x.
- Results publication: PubMed 22791040Desai A, Bekelis K, Ball PA, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Spine patient outcomes research trial: do outcomes vary across centers for surgery for lumbar disc herniation? Neurosurgery. 2012 Oct;71(4):833-42. doi: 10.1227/NEU.0b013e31826772cb.
- Results publication: PubMed 10740540Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
- Results publication: PubMed 14576554Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.
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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 in people with Rocuronium and Lumbar Discectomy, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
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 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 Jan 2020. 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 Croatia. 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?
Change in muscle strength (time frame: perioperative). The study lists 2 primary outcomes in all. 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 NCT04236050, which also lists 9 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 22 Jan 2020.