Neuromuscular BlockadeNCT02984839
Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study
An observational study of Neuromuscular Blockade and Pulmonary Complication, run by OhioHealth at 1 site in United States.
Trial summary
The aim of this prospective, observational study is to determine the incidence of post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures that also require non-depolarizing neuromuscular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Pulmonary Complication
- What is being tested?
- Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 16 May 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include all patients age 18 or older with American Society of Anesthesiologists (ASA) physical status I-IV presenting for elective or non-elective surgery requiring general anesthesia with neuromuscular blockade.While previous studies have found that up to 30-42% of patients experience PRNB in the PACU, no previous studies have estimated the incidence of PRNB by surgical procedure (i.e., intra-abdominal versus other surgical procedures).Therefore, this study will be more descriptive in nature.A difference of at least 10% in the incidence of PRNB between the two groups will be considered clinically significant.A maximum number of 120 (approximately 60 patients who undergo intra-abdominal surgery and 60 patients who undergo non intra-abdominal surgical procedures) will be enrolled during the course of the study.
Who may be able to join
- English speaking
- ASA physical status classification I-IV
- Procedures requiring intubation and nondepolarizing NMBA administration
- Laparoscopic surgery
- Intra-abdominal surgery
- Procedures using the Da Vinci surgical system
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- Tonsillectomy
- Septoplasty
- Shoulder surgery
- Total hip arthroplasty
- Carotid endarterectomy
- Cervical spine surgery
- Parotidectomy
- Thyroidectomy
- Aorto-bifemoral bypass
- Micro laryngoscopy
- Nasal or sinus surgery
- Dental extraction
Who cannot join
- Non-English speaking population
- ASA V and VI
- Unable to give informed consent
- Cardiac or intra-thoracic procedures performed
- Severe renal insufficiency (Serum Creatinine >2.0 mg/dL)
- Severe hepatic dysfunction
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- Underlying neuromuscular disease
- Currently enrolled in another therapeutic study
- Pregnant patients at any stage of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective, observational study is to determine the incidence of post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As intra-abdominal surgeries are independently associated with post-operative pulmonary complications (PPCs), it is important to highlight other factors, such as PRNB, that could contribute to these complications.Although it has been shown that the risk of adverse respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring, such monitoring is not in widespread use.This study will incorporate quantitative monitoring in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to show a disparity in the incidence of residual paralysis between these two patient populations and to emphasize the need to implement more accurate neuromuscular monitoring, especially for those that are already at increased risk for respiratory complications.
Read the detailed description
Residual paralysis from non-depolarizing neuromuscular blocking agents (NMBAs) is a common problem that contributes to adverse outcomes in the post-anesthesia care unit (PACU).Unidentified residual neuromuscular blockade (defined as a train-of-four (TOF) ratio <0.9) has been reported in up to 30-42% of patients in the recovery room.Though current literature supports the use of quantitative monitoring of neuromuscular blockade, conventional qualitative TOF count monitoring and clinical signs (head lift, grip strength) continue to be used.There is strong evidence that shows reduction of clinically significant post-operative residual neuromuscular blockade (PRNB) after implementation of quantitative monitoring. Post-operative pulmonary complications (PPCs) are notable adverse outcomes of residual neuromuscular blockade. The implementation of quantitative monitoring may be particularly beneficial to patients who are already predisposed to PPCs secondary to the site of surgery.
The purpose of this study is to evaluate the incidence of PRNB with use of quantitative neuromuscular monitoring in patients undergoing intra-abdominal procedures compared to patients undergoing other surgical procedures that also require NMBA administration.
- Conditions
- Neuromuscular Blockade, Pulmonary Complication
- Being tested
- Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology
- Keywords
- intra-abdominal surgery, neuromuscular blocking agent, post-anesthesia care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimpod NMS450® Nerve Stimulator, by Xavant™ TechnologyDevice
Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450
| Study group | Role | What they receive |
|---|---|---|
| Intra-abdominal surgery group | The study population will include patients presenting for elective or non-elective intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital.
Quantitative TOF will be recorded by Stimpod NMS450 in PACU. Receives: Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology | |
| Non-intra-abdominal surgery group | The study population will include patients presenting for elective or non-elective non intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital.
Quantitative TOF will be recorded by Stimpod NMS450 in PACU. Receives: Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Train-of-four (TOF) ratio
Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU
Measured: 15 minutes post arrival in the post anesthesia care unit (PACU)
Secondary outcomes (1)
Need for supplemental O2 therapy
Necessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication
Measured: 30 minutes post arrival in the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion21 Mar 2017
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kayla Petersen, OhioHealth
- Investigators
- Kayla Petersen, D.O., Principal investigator, Resident Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984839
- Sponsor's protocol ID
- 16-0047
- Status last verified
- Jul 2018
- First submitted
- 3 Dec 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02984839
- Acronym / sponsor ID
- 16-0047
- Conditions
- Neuromuscular Blockade, Pulmonary Complication
- Keywords
- intra-abdominal surgery, neuromuscular blocking agent, post-anesthesia care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- 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 prospective, observational study is to determine the incidence of post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As intra-abdominal surgeries are independently associated with post-operative pulmonary complications (PPCs), it is important to highlight other factors, such as PRNB, that could contribute to these complications.Although it has been shown that the risk of adverse respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring, such monitoring is not in widespread use.This study will incorporate quantitative monitoring in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to show a disparity in the incidence of residual paralysis between these two patient populations and to emphasize the need to implement more accurate neuromuscular monitoring, especially for those that are already at increased risk for respiratory complications.
Detailed description
Residual paralysis from non-depolarizing neuromuscular blocking agents (NMBAs) is a common problem that contributes to adverse outcomes in the post-anesthesia care unit (PACU).Unidentified residual neuromuscular blockade (defined as a train-of-four (TOF) ratio <0.9) has been reported in up to 30-42% of patients in the recovery room.Though current literature supports the use of quantitative monitoring of neuromuscular blockade, conventional qualitative TOF count monitoring and clinical signs (head lift, grip strength) continue to be used.There is strong evidence that shows reduction of clinically significant post-operative residual neuromuscular blockade (PRNB) after implementation of quantitative monitoring. Post-operative pulmonary complications (PPCs) are notable adverse outcomes of residual neuromuscular blockade. The implementation of quantitative monitoring may be particularly beneficial to patients who are already predisposed to PPCs secondary to the site of surgery.
The purpose of this study is to evaluate the incidence of PRNB with use of quantitative neuromuscular monitoring in patients undergoing intra-abdominal procedures compared to patients undergoing other surgical procedures that also require NMBA administration.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-abdominal surgery group | – | Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ TechnologyThe study population will include patients presenting for elective or non-elective intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital. Quantitative TOF will be recorded by Stimpod NMS450 in PACU. |
| Non-intra-abdominal surgery group | – | Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ TechnologyThe study population will include patients presenting for elective or non-elective non intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital. Quantitative TOF will be recorded by Stimpod NMS450 in PACU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all patients age 18 or older with American Society of Anesthesiologists (ASA) physical status I-IV presenting for elective or non-elective surgery requiring general anesthesia with neuromuscular blockade.While previous studies have found that up to 30-42% of patients experience PRNB in the PACU, no previous studies have estimated the incidence of PRNB by surgical procedure (i.e., intra-abdominal versus other surgical procedures).Therefore, this study will be more descriptive in nature.A difference of at least 10% in the incidence of PRNB between the two groups will be considered clinically significant.A maximum number of 120 (approximately 60 patients who undergo intra-abdominal surgery and 60 patients who undergo non intra-abdominal surgical procedures) will be enrolled during the course of the study.
Key inclusion criteria (18 listed)
- English speaking
- ASA physical status classification I-IV
- Procedures requiring intubation and nondepolarizing NMBA administration
Key exclusion criteria (9 listed)
- Non-English speaking population
- ASA V and VI
- Unable to give informed consent
- Cardiac or intra-thoracic procedures performed
- Severe renal insufficiency (Serum Creatinine >2.0 mg/dL)
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 |
|---|---|---|
| Stimpod NMS450® Nerve Stimulator, by Xavant™ TechnologyQuantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450 | Device | Intra-abdominal surgery group, Non-intra-abdominal surgery group |
Primary outcome
Train-of-four (TOF) ratio
Time frame: 15 minutes post arrival in the post anesthesia care unit (PACU)
Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU
1 secondary outcome
Need for supplemental O2 therapy
Time frame: 30 minutes post arrival in the PACU
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 26 Jul 2018.
- 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.
Kayla Petersen, D.O. principal investigator
Resident Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Pulmonary Complication, run by OhioHealth at 1 site in United States.
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 18 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 26 Jul 2018. 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 United States. 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?
Train-of-four (TOF) ratio (time frame: 15 minutes post arrival in the post anesthesia care unit (PACU)). 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 26 Jul 2018.