Residual Neuromuscular Blockade in Elderly PatientsNCT01545193
The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade
An observational study of Residual Neuromuscular Blockade in Elderly Patients, run by Endeavor Health at 1 site in United States.
Trial summary
Residual neuromuscular blockade is frequently observed in the early postoperative period when patients have received a general anesthetic with muscle relaxants. At the present time it is uncertain whether certain patient populations are at greater risk for this common anesthetic complication. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Residual Neuromuscular Blockade in Elderly Patients
- What is being tested?
- Age and incidence of residual neuromuscular blockade
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2014
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing general anesthesia and surgery
Who may be able to join
- Patients presenting for elective surgical procedures with an expected duration greater than 45 minutes.
- ASA I to III patients ≥ 18 years of age, presenting for surgery requiring maintenance of neuromuscular blockade in the operating room, will be eligible for enrollment.
Who cannot join
- presence of an underlying neuromuscular disease
- use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate)
- renal insufficiency (serum creatinine > 1.8 mg/dL) or renal failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Residual neuromuscular blockade is frequently observed in the early postoperative period when patients have received a general anesthetic with muscle relaxants. At the present time it is uncertain whether certain patient populations are at greater risk for this common anesthetic complication. However, it is possible that elderly surgical patients may exhibit a higher incidence of residual neuromuscular blockade. The aim of this clinical trial is to determine the incidence of residual neuromuscular blockade in a cohort of younger (ages 18-50) and older (ages 70-90) patients undergoing surgery and general anesthesia.
Read the detailed description
300 patients will be enrolled in this study. Patients will be selected for enrollment by reviewing the operating room schedule on the day prior to the procedure. Two groups of patients will be examined; group 1 will consist of patients ages 18-50 (n=150) and group 2 will consist of patients age 70-90 (n=150). Patients will be enrolled in blocks of 20 to ensure an equal distribution of subjects in each age group over time.
Anesthetic and neuromuscular management will be standardized in both study cohorts
Neuromuscular Monitoring:
On arrival to the PACU, a blinded research assistant will obtain a quantitative TOF measurement in all subjects. The TOF-Watch SX will be used to obtain these measurements. Two consecutive responses to TOF stimulation (separated by > 15 seconds) will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.7, 0.8, and 0.9 (which are levels of residual neuromuscular block associated with various adverse clinical outcomes) in each group will be compared.
Signs and Symptoms of Residual Neuromuscular Blockade After TOF data is collected on arrival to the PACU, the patients will be carefully examined for signs and symptoms of muscle weakness by a blinded research assistant. A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission.
Respiratory Events Potentially Related to Residual Neuromuscular Blockade
Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Patients will be transported to the PACU without supplemental oxygen (unless the anesthesia care provider determines that oxygen therapy is required for patient safety-per standard practice). All patients will be placed on 2 liters nasal cannula oxygen in the PACU. In the PACU, pulse oximetry will be used to continuously measure Sp02. Oxygenation data will be stored and recorded every minute for the first 30 minutes of the PACU admission. In addition to oxygenation data, patients will be assessed during transportation to the PACU and during the first 30 minutes of the PACU admission for evidence of airway obstruction.
PACU Length of Stay The impact of age and residual blockade on length of PACU stay will be determined. The time required to meet discharge criteria and achieve actual discharge will be noted.
- Being tested
- Age and incidence of residual neuromuscular blockade
- Keywords
- Elderly, Residual neuromuscular blockade
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age and incidence of residual neuromuscular blockadeOther
An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
| Study group | Role | What they receive |
|---|---|---|
| Age 18-50 | This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade Receives: Other: Age and incidence of residual neuromuscular blockade | |
| Age 70-90 | This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade Receives: Other: Age and incidence of residual neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Residual Neuromuscular Blockade
The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.9 in each group will be compared.
Measured: Early postoperative period, up to 24 hours
Secondary outcomes (3)
Signs and Symptoms of Residual Neuromuscular Blockade
A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission
Measured: Early postoperative period, up to 24 hours
Respiratory Events Potentially Related to Residual Neuromuscular Blockade
Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation < 94% on pulse oximetry) in the PACU
Measured: Early postoperative period, up to 24 hours
PACU Length of Stay
The time required to meet discharge criteria and achieve actual discharge will be noted.
Measured: Early postoperative period, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionSep 2013
- Study completionSep 2014
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.
- Other trials for Residual Neuromuscular Blockade in Elderly PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Murphy, Endeavor Health
- Investigators
- Glenn S. Murphy, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545193
- Sponsor's protocol ID
- EH11-045
- Status last verified
- Sep 2019
- First submitted
- 1 Mar 2012
- Last updated
- 16 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT01545193
- Acronym / sponsor ID
- EH11-045
- Keywords
- Elderly, Residual neuromuscular blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Residual neuromuscular blockade is frequently observed in the early postoperative period when patients have received a general anesthetic with muscle relaxants. At the present time it is uncertain whether certain patient populations are at greater risk for this common anesthetic complication. However, it is possible that elderly surgical patients may exhibit a higher incidence of residual neuromuscular blockade. The aim of this clinical trial is to determine the incidence of residual neuromuscular blockade in a cohort of younger (ages 18-50) and older (ages 70-90) patients undergoing surgery and general anesthesia.
Detailed description
300 patients will be enrolled in this study. Patients will be selected for enrollment by reviewing the operating room schedule on the day prior to the procedure. Two groups of patients will be examined; group 1 will consist of patients ages 18-50 (n=150) and group 2 will consist of patients age 70-90 (n=150). Patients will be enrolled in blocks of 20 to ensure an equal distribution of subjects in each age group over time.
Anesthetic and neuromuscular management will be standardized in both study cohorts
Neuromuscular Monitoring:
On arrival to the PACU, a blinded research assistant will obtain a quantitative TOF measurement in all subjects. The TOF-Watch SX will be used to obtain these measurements. Two consecutive responses to TOF stimulation (separated by > 15 seconds) will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.7, 0.8, and 0.9 (which are levels of residual neuromuscular block associated with various adverse clinical outcomes) in each group will be compared.
Signs and Symptoms of Residual Neuromuscular Blockade After TOF data is collected on arrival to the PACU, the patients will be carefully examined for signs and symptoms of muscle weakness by a blinded research assistant. A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission.
Respiratory Events Potentially Related to Residual Neuromuscular Blockade
Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Patients will be transported to the PACU without supplemental oxygen (unless the anesthesia care provider determines that oxygen therapy is required for patient safety-per standard practice). All patients will be placed on 2 liters nasal cannula oxygen in the PACU. In the PACU, pulse oximetry will be used to continuously measure Sp02. Oxygenation data will be stored and recorded every minute for the first 30 minutes of the PACU admission. In addition to oxygenation data, patients will be assessed during transportation to the PACU and during the first 30 minutes of the PACU admission for evidence of airway obstruction.
PACU Length of Stay The impact of age and residual blockade on length of PACU stay will be determined. The time required to meet discharge criteria and achieve actual discharge will be noted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 18-50 | – | Other: Age and incidence of residual neuromuscular blockadeThis is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade |
| Age 70-90 | – | Other: Age and incidence of residual neuromuscular blockadeThis is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing general anesthesia and surgery
Key inclusion criteria (2 listed)
- Patients presenting for elective surgical procedures with an expected duration greater than 45 minutes.
- ASA I to III patients ≥ 18 years of age, presenting for surgery requiring maintenance of neuromuscular blockade in the operating room, will be eligible for enrollment.
Key exclusion criteria (3 listed)
- presence of an underlying neuromuscular disease
- use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate)
- renal insufficiency (serum creatinine > 1.8 mg/dL) or renal failure.
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 |
|---|---|---|
| Age and incidence of residual neuromuscular blockadeAn older cohort is anticipated to have a higher incidence of residual neuromuscular blockade | Other | Age 18-50, Age 70-90 |
Primary outcome
Incidence of Residual Neuromuscular Blockade
Time frame: Early postoperative period, up to 24 hours
The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.9 in each group will be compared.
3 secondary outcomes
Signs and Symptoms of Residual Neuromuscular Blockade
Time frame: Early postoperative period, up to 24 hours
Respiratory Events Potentially Related to Residual Neuromuscular Blockade
Time frame: Early postoperative period, up to 24 hours
PACU Length of Stay
Time frame: Early postoperative period, up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Glenn S. Murphy, MD principal investigator
Endeavor Health
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 Residual Neuromuscular Blockade in Elderly Patients, run by Endeavor Health 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 2 inclusion and 3 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 16 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2015). 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?
Incidence of Residual Neuromuscular Blockade (time frame: Early postoperative period, up to 24 hours). 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 16 Sep 2019.