Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post--‐Anesthesia Care Unit
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/28/2017 |
| Start Date: | February 16, 2017 |
| End Date: | July 31, 2018 |
| Contact: | Jaideep H Mehta, MD |
| Email: | Jaideep.H.Mehta@uth.tmc.edu |
| Phone: | 713-530-7338 |
Randomized Double--‐Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post--‐Anesthesia Care Unit as Evaluated With a Non--‐Invasive Respiratory Volume Monitor
The Primary objective of this study is to determine whether patients who receive sugammadex
immediately after tracheal extubation will exhibit a decrease in the incidence of
postoperative residual paralysis and an associated decrease in the incidence of postoperative
respiratory depression (which can precede critical respiratory events, CRE).
The Secondary objectives are to: a) determine whether patients receiving sugammadex will have
a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the PACU; and b) to
improve patient safety by documenting whether postoperative respiratory depression (decreased
MV below 80% and 40% of predicted MV as assessed by a Respiratory Volume Monitor) is due to
opioid administration vs. postoperative residual neuromuscular block (by comparing
postoperative VAS scores and total opioid administered).
immediately after tracheal extubation will exhibit a decrease in the incidence of
postoperative residual paralysis and an associated decrease in the incidence of postoperative
respiratory depression (which can precede critical respiratory events, CRE).
The Secondary objectives are to: a) determine whether patients receiving sugammadex will have
a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the PACU; and b) to
improve patient safety by documenting whether postoperative respiratory depression (decreased
MV below 80% and 40% of predicted MV as assessed by a Respiratory Volume Monitor) is due to
opioid administration vs. postoperative residual neuromuscular block (by comparing
postoperative VAS scores and total opioid administered).
The Investigators plan to enroll 300 patients undergoing surgical procedures requiring
general anesthesia with mechanical ventilation will be recruited and consent will be
obtained. The subjects will be randomized preoperatively to receive in the OR following the
procedure and prior to extubation either sugammadex (Group 1, n=150 patients) or placebo
(Group 2, n=150 patients). In all patients, intraoperative surgical and anesthetic management
will follow the usual clinical routine at the two enrolling institutions. Once surgery is
finished, emergence from anesthesia will occur as per usual clinical routine until the
clinician determines that the patient is ready for tracheal extubation. Once the decision to
extubate the trachea is made, the patient will receive intravenously either sugammadex 2
mg/kg or placebo in a blinded manner. The patient's trachea will be then extubated, and
postoperative anesthetic care will proceed as per usual routine. Patients will then be
transferred to the PACU for postoperative care and recovery. (This methodology will ensure
that all 300 patients will receive at least the current standard of clinical care. Of the 300
patients, 50% of them (n=150 patients) may benefit from the administration of sugammadex,
which may decrease the incidence of residual neuromuscular block.)
1. The ExSpiron will be placed on the patients' chest prior to extubation. ExSpiron data
will be collected starting prior to tracheal extubation, during transport from OR to
PACU, and in PACU.
2. Patient care staff will be blinded to the ExSpiron numerical and trending data for MV,
TV and RR, but the respiratory trace will be displayed to demonstrate that the ExSpiron
is functioning. Of note, the gain on the trace is variable so the size of the breath
visualized on the screen is not correlated to the volume of the breath. This will
maintain blinding of the patient care staff.
3. TOF Monitoring with an objective monitor (TOF--Watch or StimPod) will be used in all
patients once the decision to extubate the patients' trachea is made. The monitoring
will continue in the PACU until full recovery (TOF=1.0) is documented. Monitoring will
be performed as per usual clinical routine via surface ECG electrodes. In the PACU, the
current amplitude will be decreased to 30--‐40 mA, current intensities that are used
routinely for patient care in other centers and that do not result in patient
discomfort.
4. Patient care staff will be blinded to TOF data. Only the investigator assigned to the
PACU data retrieval will know the results of TOF Monitoring.
5. Patient care should follow standard hospital protocol.
6. Physiologic monitoring and clinical assessment data will be recorded as per standard
protocol in the PACU.
7. All other therapies and medications including oxygen, CPAP, opioids and sedatives will
be delivered in accordance with standard of care.
8. Doses and times of all medications (such as opioids, sedatives, etc.) or respiratory
interventions (such as albuterol, respiratory treatment, suctioning, high flow oxygen,
CPAP, BiPAP, etc.) will be recorded throughout the entire perioperative period
(pre--‐op, OR, PACU).
9. Pain scores based on a standard analog scale (1--‐10) will be recorded. These will be
obtained per standard clinical practice.
10. Arterial or venous blood gas values and Chest x--‐rays taken in the OR or PACU will be
recorded when obtained as part of standard care.
B. Study Procedures
1. Screening and Recruitment:
Study personnel will review the surgery schedule to identify appropriate and eligible
patients. Eligible patients will be informed about the study and the study will be
explained to them or their parent, guardian or legal representative. They will be able
to ask questions. If they would like to participate, written informed consent will be
obtained.
2. Randomization:
Patients will be randomized to one of two groups:
administration of sugammadex (n=150) vs. placebo (n=150) prior to tracheal extubation in
the OR.
3. Prior to Procedure (in the OR or preoperative area):
I. For RVM monitoring, ExSpiron PadSet will be placed on the patient's thorax (see
Appendix A for placement instructions). Deviations from standard placement will be
documented. Once in the OR the ExSpiron will be connected and the ExSpiron will be
synchronized to the ventilator.
ii. For TOF monitoring, skin ECG electrodes will be placed along the ulnar nerve on the
volar forearm, as per routine clinical protocol. Visual or tactile intraoperative
monitoring of neuromuscular block level will be performed according to the clinicians'
usual routine. At the end of surgery, once the clinician has determined that recovery of
neuromuscular block is adequate for maintenance of spontaneous ventilation, the TOF will
be determined objectively (it will be measured with the currently available monitor,
TOF--‐Watch or StimPod), and then the patient's trachea will be extubated, as per usual
clinical routine. In 150 of the 300 patients, a dose of sugammadex (2 mg/kg) will be
administered, and then routine TOF measurements will be made in the PACU.
4. Operating Room (OR):
1. Record all medications (dose, route, time)
2. Record surgery start and end times
3. Record position changes
4. Record intubation and extubation times
5. Recovery Room (PACU):
1. Record PACU arrival and check device function.
2. Record all medications (dose, route, time)
3. Record form and dose of administered oxygen & all changes in administered oxygen or
respiratory treatments of any kind
4. Record PACU discharge time
5. MV, TV & RR numerical data will be hidden and not available for patient care
decisions, but the continuous respiratory trace will be displayed. Patient care
providers should not use this trace for clinical decision--‐making. If the trace is
absent or grossly abnormal, this should be recorded and study staff notified to
ensure proper device function.
6. TOF data will be hidden and not available for patient care decisions
6. Final Discharge Parameters: Record the patients' final discharge date and time (LOS)
from the PACU.
7. De--‐identification: All study data will be de--‐identified and identifying information
will be linked to a code only accessible to the study staff. The code will be destroyed
following final data analysis.
8. Assessment of Subject Safety and Data Safety Monitoring Plan: All patients will be
followed by one of the study investigators to ensure there are no complications
associated with sugammadex administration (flushing, tachycardia, hypotension, etc).
There are no expected complications of RVM monitoring. There are no expected
complications associated with TOF monitoring, and in fact, such monitoring has been
shown to improve patient safety by decreasing postoperative CREs and other
complications.
9. Subject Participation:
1. Recruitment: Subjects will be recruited in the pre--‐ procedure holding areas by
the study team members prior to their surgery.
2. Screening Interview: Subject screening will be based on study personnel examining
the surgery schedule of the next or same day to identify appropriate procedures
scheduled and patient's eligibility.
3. Informed consent process and timing of obtaining of consent: Informed consent will
be obtained by the study staff prior to surgery in the preoperative holding area,
in patients requiring surgery and general anesthesia and planned extubation in the
OR. After a thorough review of the study. Sufficient time will be given to the
patients, parents, guardians or legal representative to ask questions and decide on
participation.
4. Location where study will be performed: University of Texas, UTHealth at Houston
and Mayo Clinic, Jacksonville, Florida operating holding areas, operating and
recovery rooms, and intensive care units as applicable.
5. Personnel who will conduct the study include PI and research team members.
10. Subject fees: There are no fees for this study.
11. Procedures to protect subject confidentiality: A unique study ID number will be assigned
to each subject as a means to de--‐identify the study data. A code will be kept
separately with the PI. Study files will be kept in a locked office in a locked cabinet
or a password--‐protected computer with encrypted study files. The location will be the
PI office with restricted access. The code will be locked separately from study files in
the PI office.
1. Certificate of Confidentiality: N/A
2. How data will be coded, recorded, and stored to protect confidentiality: All data
will be de--‐ identified. All data will be linked to the subject study ID by a
code.
3. Data will be analyzed by institutional biostatisticians at UTHealth at Houston.
4. Parties who will have access to the data, including the key to the identity code:
only Jaideep Mehta, MD and Sorin J. Brull, MD and primary study staff will have
access to the master study log/key. Other investigators and the clinical and
engineering staff at Respiratory Motion, Inc. will only have access to
de--‐identified data.
5. Parties who will have access to research records: Investigators on the study,
Respiratory Motion, Inc. will have access only to de--‐identified records.
6. Collaboration: This study is performed in collaboration with Respiratory Motion,
Inc.
7. Alternatives: The alternative to participating in this study is not participating.
8. How new information will be conveyed to the study subject and how it will be
documented: Other than the initial explanation of the purpose and plan for the
study, the investigators don't expect new information to become available from the
study that could affect a subject's willingness to participate. No new information
of clinical relevance to the subject is expected from this study. Therefore, no new
information will be given to the patient.
9. Payment for a research--‐related injury: This is a minimal risk study. There are no
plans to provide other compensation. If a participant is injured during this study,
the study doctor will discuss the available medical treatment options with the
subject.
12. Outcome: The primary outcome of this study is evaluation of the effects of sugammadex on
the incidence of respiration complications postoperatively.
general anesthesia with mechanical ventilation will be recruited and consent will be
obtained. The subjects will be randomized preoperatively to receive in the OR following the
procedure and prior to extubation either sugammadex (Group 1, n=150 patients) or placebo
(Group 2, n=150 patients). In all patients, intraoperative surgical and anesthetic management
will follow the usual clinical routine at the two enrolling institutions. Once surgery is
finished, emergence from anesthesia will occur as per usual clinical routine until the
clinician determines that the patient is ready for tracheal extubation. Once the decision to
extubate the trachea is made, the patient will receive intravenously either sugammadex 2
mg/kg or placebo in a blinded manner. The patient's trachea will be then extubated, and
postoperative anesthetic care will proceed as per usual routine. Patients will then be
transferred to the PACU for postoperative care and recovery. (This methodology will ensure
that all 300 patients will receive at least the current standard of clinical care. Of the 300
patients, 50% of them (n=150 patients) may benefit from the administration of sugammadex,
which may decrease the incidence of residual neuromuscular block.)
1. The ExSpiron will be placed on the patients' chest prior to extubation. ExSpiron data
will be collected starting prior to tracheal extubation, during transport from OR to
PACU, and in PACU.
2. Patient care staff will be blinded to the ExSpiron numerical and trending data for MV,
TV and RR, but the respiratory trace will be displayed to demonstrate that the ExSpiron
is functioning. Of note, the gain on the trace is variable so the size of the breath
visualized on the screen is not correlated to the volume of the breath. This will
maintain blinding of the patient care staff.
3. TOF Monitoring with an objective monitor (TOF--Watch or StimPod) will be used in all
patients once the decision to extubate the patients' trachea is made. The monitoring
will continue in the PACU until full recovery (TOF=1.0) is documented. Monitoring will
be performed as per usual clinical routine via surface ECG electrodes. In the PACU, the
current amplitude will be decreased to 30--‐40 mA, current intensities that are used
routinely for patient care in other centers and that do not result in patient
discomfort.
4. Patient care staff will be blinded to TOF data. Only the investigator assigned to the
PACU data retrieval will know the results of TOF Monitoring.
5. Patient care should follow standard hospital protocol.
6. Physiologic monitoring and clinical assessment data will be recorded as per standard
protocol in the PACU.
7. All other therapies and medications including oxygen, CPAP, opioids and sedatives will
be delivered in accordance with standard of care.
8. Doses and times of all medications (such as opioids, sedatives, etc.) or respiratory
interventions (such as albuterol, respiratory treatment, suctioning, high flow oxygen,
CPAP, BiPAP, etc.) will be recorded throughout the entire perioperative period
(pre--‐op, OR, PACU).
9. Pain scores based on a standard analog scale (1--‐10) will be recorded. These will be
obtained per standard clinical practice.
10. Arterial or venous blood gas values and Chest x--‐rays taken in the OR or PACU will be
recorded when obtained as part of standard care.
B. Study Procedures
1. Screening and Recruitment:
Study personnel will review the surgery schedule to identify appropriate and eligible
patients. Eligible patients will be informed about the study and the study will be
explained to them or their parent, guardian or legal representative. They will be able
to ask questions. If they would like to participate, written informed consent will be
obtained.
2. Randomization:
Patients will be randomized to one of two groups:
administration of sugammadex (n=150) vs. placebo (n=150) prior to tracheal extubation in
the OR.
3. Prior to Procedure (in the OR or preoperative area):
I. For RVM monitoring, ExSpiron PadSet will be placed on the patient's thorax (see
Appendix A for placement instructions). Deviations from standard placement will be
documented. Once in the OR the ExSpiron will be connected and the ExSpiron will be
synchronized to the ventilator.
ii. For TOF monitoring, skin ECG electrodes will be placed along the ulnar nerve on the
volar forearm, as per routine clinical protocol. Visual or tactile intraoperative
monitoring of neuromuscular block level will be performed according to the clinicians'
usual routine. At the end of surgery, once the clinician has determined that recovery of
neuromuscular block is adequate for maintenance of spontaneous ventilation, the TOF will
be determined objectively (it will be measured with the currently available monitor,
TOF--‐Watch or StimPod), and then the patient's trachea will be extubated, as per usual
clinical routine. In 150 of the 300 patients, a dose of sugammadex (2 mg/kg) will be
administered, and then routine TOF measurements will be made in the PACU.
4. Operating Room (OR):
1. Record all medications (dose, route, time)
2. Record surgery start and end times
3. Record position changes
4. Record intubation and extubation times
5. Recovery Room (PACU):
1. Record PACU arrival and check device function.
2. Record all medications (dose, route, time)
3. Record form and dose of administered oxygen & all changes in administered oxygen or
respiratory treatments of any kind
4. Record PACU discharge time
5. MV, TV & RR numerical data will be hidden and not available for patient care
decisions, but the continuous respiratory trace will be displayed. Patient care
providers should not use this trace for clinical decision--‐making. If the trace is
absent or grossly abnormal, this should be recorded and study staff notified to
ensure proper device function.
6. TOF data will be hidden and not available for patient care decisions
6. Final Discharge Parameters: Record the patients' final discharge date and time (LOS)
from the PACU.
7. De--‐identification: All study data will be de--‐identified and identifying information
will be linked to a code only accessible to the study staff. The code will be destroyed
following final data analysis.
8. Assessment of Subject Safety and Data Safety Monitoring Plan: All patients will be
followed by one of the study investigators to ensure there are no complications
associated with sugammadex administration (flushing, tachycardia, hypotension, etc).
There are no expected complications of RVM monitoring. There are no expected
complications associated with TOF monitoring, and in fact, such monitoring has been
shown to improve patient safety by decreasing postoperative CREs and other
complications.
9. Subject Participation:
1. Recruitment: Subjects will be recruited in the pre--‐ procedure holding areas by
the study team members prior to their surgery.
2. Screening Interview: Subject screening will be based on study personnel examining
the surgery schedule of the next or same day to identify appropriate procedures
scheduled and patient's eligibility.
3. Informed consent process and timing of obtaining of consent: Informed consent will
be obtained by the study staff prior to surgery in the preoperative holding area,
in patients requiring surgery and general anesthesia and planned extubation in the
OR. After a thorough review of the study. Sufficient time will be given to the
patients, parents, guardians or legal representative to ask questions and decide on
participation.
4. Location where study will be performed: University of Texas, UTHealth at Houston
and Mayo Clinic, Jacksonville, Florida operating holding areas, operating and
recovery rooms, and intensive care units as applicable.
5. Personnel who will conduct the study include PI and research team members.
10. Subject fees: There are no fees for this study.
11. Procedures to protect subject confidentiality: A unique study ID number will be assigned
to each subject as a means to de--‐identify the study data. A code will be kept
separately with the PI. Study files will be kept in a locked office in a locked cabinet
or a password--‐protected computer with encrypted study files. The location will be the
PI office with restricted access. The code will be locked separately from study files in
the PI office.
1. Certificate of Confidentiality: N/A
2. How data will be coded, recorded, and stored to protect confidentiality: All data
will be de--‐ identified. All data will be linked to the subject study ID by a
code.
3. Data will be analyzed by institutional biostatisticians at UTHealth at Houston.
4. Parties who will have access to the data, including the key to the identity code:
only Jaideep Mehta, MD and Sorin J. Brull, MD and primary study staff will have
access to the master study log/key. Other investigators and the clinical and
engineering staff at Respiratory Motion, Inc. will only have access to
de--‐identified data.
5. Parties who will have access to research records: Investigators on the study,
Respiratory Motion, Inc. will have access only to de--‐identified records.
6. Collaboration: This study is performed in collaboration with Respiratory Motion,
Inc.
7. Alternatives: The alternative to participating in this study is not participating.
8. How new information will be conveyed to the study subject and how it will be
documented: Other than the initial explanation of the purpose and plan for the
study, the investigators don't expect new information to become available from the
study that could affect a subject's willingness to participate. No new information
of clinical relevance to the subject is expected from this study. Therefore, no new
information will be given to the patient.
9. Payment for a research--‐related injury: This is a minimal risk study. There are no
plans to provide other compensation. If a participant is injured during this study,
the study doctor will discuss the available medical treatment options with the
subject.
12. Outcome: The primary outcome of this study is evaluation of the effects of sugammadex on
the incidence of respiration complications postoperatively.
Inclusion Criteria:
- Patients undergoing surgery with general anesthesia,
- Patients weighing ≥ 80 pounds who are not -intubated prior to surgery,
- Patients who are able to give informed consent.
Exclusion Criteria:
- Patients unable to give informed consent.
- Any patient whose condition will not allow for placement of the electrode PadSet.
- Patients whose tracheas were not extubated in OR or PACU.
- Patients with Impaired Renal Function with a have a known estimated CrCl<30 ml/min
- Patients using oral contraception.
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