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The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade

The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01545193
Enrollment
300
Registered
2012-03-06
Start date
2011-06-30
Completion date
2014-09-30
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residual Neuromuscular Blockade in Elderly Patients

Keywords

Elderly, Residual neuromuscular blockade

Brief 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. 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.

Interventions

OTHERAge and incidence of residual neuromuscular blockade

An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

1. presence of an underlying neuromuscular disease 2. use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate) 3. renal insufficiency (serum creatinine \> 1.8 mg/dL) or renal failure.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Residual Neuromuscular BlockadeEarly postoperative period, up to 24 hoursThe 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.

Secondary

MeasureTime frameDescription
Signs and Symptoms of Residual Neuromuscular BlockadeEarly postoperative period, up to 24 hoursA 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
Respiratory Events Potentially Related to Residual Neuromuscular BlockadeEarly postoperative period, up to 24 hoursPulse 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
PACU Length of StayEarly postoperative period, up to 24 hoursThe time required to meet discharge criteria and achieve actual discharge will be noted.

Countries

United States

Participant flow

Participants by arm

ArmCount
Age 18-50
This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
150
Age 70-90
This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
149
Total299

Baseline characteristics

CharacteristicAge 70-90Age 18-50Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
149 Participants0 Participants149 Participants
Age, Categorical
Between 18 and 65 years
0 Participants150 Participants150 Participants
Age, Continuous75 years38 years57 years
Region of Enrollment
United States
149 participants150 participants299 participants
Sex: Female, Male
Female
84 Participants98 Participants182 Participants
Sex: Female, Male
Male
65 Participants52 Participants117 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1500 / 149
serious
Total, serious adverse events
0 / 1500 / 149

Outcome results

Primary

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.

Time frame: Early postoperative period, up to 24 hours

ArmMeasureValue (NUMBER)
Age 18-50Incidence of Residual Neuromuscular Blockade45 participants
Age 70-90Incidence of Residual Neuromuscular Blockade86 participants
Secondary

PACU Length of Stay

The time required to meet discharge criteria and achieve actual discharge will be noted.

Time frame: Early postoperative period, up to 24 hours

ArmMeasureValue (MEDIAN)
Age 18-50PACU Length of Stay73 minutes
Age 70-90PACU Length of Stay92 minutes
Secondary

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

Time frame: Early postoperative period, up to 24 hours

ArmMeasureValue (NUMBER)
Age 18-50Respiratory Events Potentially Related to Residual Neuromuscular Blockade26 participants
Age 70-90Respiratory Events Potentially Related to Residual Neuromuscular Blockade57 participants
Secondary

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

Time frame: Early postoperative period, up to 24 hours

ArmMeasureValue (MEDIAN)
Age 18-50Signs and Symptoms of Residual Neuromuscular Blockade2 symptoms
Age 70-90Signs and Symptoms of Residual Neuromuscular Blockade4 symptoms

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026