Observation of Neuromuscular BlockPhase 4RECITENCT01318382
Residual Curarization and Its Incidence at Tracheal Extubation (P08194)
A Phase 4 study testing TOF-Watch SX® Monitoring of NMB in people with Observation of Neuromuscular Block, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Observation of Neuromuscular Block
- What is being tested?
- TOF-Watch SX® Monitoring of NMB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to May 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be American Society of Anesthesia (ASA) class 1-3.
- Participant must be scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours.
- Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade.
- Extubation must occur in the operating room (OR).
Who cannot join
- Surgery re-admission on the same hospital admission.
- Pre-established need for or expected to require post-operative mechanical ventilation.
- Conditions, surgical procedures or position that may interfere with the TOF-Watch SX® operation, calibration or accuracy.
- Administration of sugammadex (Bridion®) for reversal of neuromuscular blockade.
- Participation in any other clinical trial.
- Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.
- Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method).
About this study
Official title: Residual Curarization and Its Incidence at Tracheal Extubation
This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.
Read the detailed description
This is an observational cohort study with a device intervention to determine in which cohort the subject is falling.
- Conditions
- Observation of Neuromuscular Block
- Being tested
- TOF-Watch SX® Monitoring of NMB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF-Watch SX® Monitoring of NMBDevice
Participants will have the extent of NMB monitored by a TOF-Watch SX®.
| Study group | Role | What they receive |
|---|---|---|
| TOF-Watch SX® | Experimental | Participants who have undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®. Receives: Device: TOF-Watch SX® Monitoring of NMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
Measured: Up to 1 minute prior to tracheal extubation
Secondary outcomes (3)
Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)
Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
Measured: Up to 2 minutes prior to PACU arrival
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation
Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.
Measured: Up to 1 minute prior to tracheal extubation
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU
Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.
Measured: Up to 2 minutes prior to PACU arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Observation of Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318382
- Sponsor's protocol ID
- P08194
- Other IDs
- MK-8616-063
- Acronym
- RECITE
- Status last verified
- May 2017
- First submitted
- 17 Mar 2011
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
PubMed 25902322
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Curarization and Its Incidence at Tracheal Extubation
- ClinicalTrials.gov ID
- NCT01318382
- Acronym / sponsor ID
- RECITE / P08194
- Conditions
- Observation of Neuromuscular Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Posted 22 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.
Detailed description
This is an observational cohort study with a device intervention to determine in which cohort the subject is falling.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOF-Watch SX® | Experimental | Device: TOF-Watch SX® Monitoring of NMBParticipants who have undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be American Society of Anesthesia (ASA) class 1-3.
- Participant must be scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours.
- Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade.
- Extubation must occur in the operating room (OR).
Key exclusion criteria (7 listed)
- Surgery re-admission on the same hospital admission.
- Pre-established need for or expected to require post-operative mechanical ventilation.
- Conditions, surgical procedures or position that may interfere with the TOF-Watch SX® operation, calibration or accuracy.
- Administration of sugammadex (Bridion®) for reversal of neuromuscular blockade.
- Participation in any other 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 |
|---|---|---|
| TOF-Watch SX® Monitoring of NMBParticipants will have the extent of NMB monitored by a TOF-Watch SX®. | Device | TOF-Watch SX® |
Primary outcome
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
Time frame: Up to 1 minute prior to tracheal extubation
Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
3 secondary outcomes
Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)
Time frame: Up to 2 minutes prior to PACU arrival
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation
Time frame: Up to 1 minute prior to tracheal extubation
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU
Time frame: Up to 2 minutes prior to PACU arrival
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25902322Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
Related trials for Observation of Neuromuscular Block
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Enrolling by invitation
EMG ss AMG In Robotic/Laparoscopic Surgery
Surgery
Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Postoperative Residual Curarization, Neuromuscular Block Prolonged
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TOF-Watch SX® Monitoring of NMB in people with Observation of Neuromuscular Block, run by Merck Sharp & Dohme LLC.
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 7 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation (time frame: Up to 1 minute prior to tracheal extubation). 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 NCT01318382, which also lists 1 linked publication.
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 9 May 2017.