Neuromuscular Blockade on Shoulder Pain of Elderly
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 9/5/2018 |
| Start Date: | November 17, 2017 |
| End Date: | November 2020 |
| Contact: | Wendell H. Williams III, MD |
| Email: | whwilliams@mdanderson.org |
| Phone: | 713-563-0034 |
The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial
Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the
abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a
common complaint from patients who have had abdominal surgery and the pain is thought to be
related to the use of IP.
In addition to anesthesia (which keeps you asleep during surgery), the current standard
practice is to block the nerve-muscle junction with a type of drug called neuromuscular
blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of
insufflation pressure is needed by the surgeon.
To reverse the effects of NMB after surgery, a drug called neostigmine is given.
The goal of this clinical research study is to compare the use of standard-of-care moderate
NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly
patients (patients who are 65 years of age or older) who are scheduled to have robotic
abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the
NMB given.
This is an investigational study. Sugammadex and neostigmine are FDA approved and
commercially available for the reversal of NMB. It is considered investigational to compare
Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can
reduce the level of shoulder pain after surgery.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a
common complaint from patients who have had abdominal surgery and the pain is thought to be
related to the use of IP.
In addition to anesthesia (which keeps you asleep during surgery), the current standard
practice is to block the nerve-muscle junction with a type of drug called neuromuscular
blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of
insufflation pressure is needed by the surgeon.
To reverse the effects of NMB after surgery, a drug called neostigmine is given.
The goal of this clinical research study is to compare the use of standard-of-care moderate
NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly
patients (patients who are 65 years of age or older) who are scheduled to have robotic
abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the
NMB given.
This is an investigational study. Sugammadex and neostigmine are FDA approved and
commercially available for the reversal of NMB. It is considered investigational to compare
Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can
reduce the level of shoulder pain after surgery.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups before your surgery. This is done because no
one knows if one group is better, the same, or worse than the other.
- In Group 1, you will receive deep NMB and Sugammadex.
- In Group 2, you will receive moderate NMB and neostigmine.
Neither you nor the surgeon or surgical staff will know to which group you have been
assigned. The surgeon will not know which group you are in because researchers want to learn
how much, if at all, the surgeon needs to adjust the insufflation pressure during surgery.
However, if needed for your safety, the surgeon will be able to find out which group you are
in.
For your safety, the anesthesiologist will know to which group you have been assigned.
Surgery and Study Drug Administration:
After you have been assigned to a study group, you will have your surgery as scheduled. You
will sign a separate consent form for surgery which describes the procedure and its risks in
more detail. You will also sign a separate consent form to receive anesthesia.
Before your surgery, blood (about 2 teaspoons) will be drawn for biomarker testing.
Biomarkers are found in the blood/tissue and may be related to the status of the disease
and/or your reaction to the study drug(s).
During the surgery, the insufflation pressure that is being used, including any changes that
are made to the pressure, will be recorded. After the surgery has been completed, you will
receive either Sugammadex or neostigmine by vein until the effects of the NMB have been
reversed.
You will recover after surgery in the post-anesthesia care unit (PACU). At about 15, 45, and
90 minutes after your surgery, a PACU nurse will ask you about any shoulder pain you are
feeling and if so, how intense the pain is. Information about how long you stay in the
hospital after surgery and if you have any side effects after surgery (such as
nausea/vomiting or shoulder pain) will also be collected from your medical record.
Follow-Up:
After 30 days after you leave the hospital, you will be called by a member of the study staff
to ask how you are doing and if you have had any additional hospitalizations since leaving
the hospital. This phone call should last about 5-10 minutes.
Length of Study Participation:
Your participation in this study will be over after completing the 30-day follow up phone
call.
If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the flip of a coin) to 1 of 2 study groups before your surgery. This is done because no
one knows if one group is better, the same, or worse than the other.
- In Group 1, you will receive deep NMB and Sugammadex.
- In Group 2, you will receive moderate NMB and neostigmine.
Neither you nor the surgeon or surgical staff will know to which group you have been
assigned. The surgeon will not know which group you are in because researchers want to learn
how much, if at all, the surgeon needs to adjust the insufflation pressure during surgery.
However, if needed for your safety, the surgeon will be able to find out which group you are
in.
For your safety, the anesthesiologist will know to which group you have been assigned.
Surgery and Study Drug Administration:
After you have been assigned to a study group, you will have your surgery as scheduled. You
will sign a separate consent form for surgery which describes the procedure and its risks in
more detail. You will also sign a separate consent form to receive anesthesia.
Before your surgery, blood (about 2 teaspoons) will be drawn for biomarker testing.
Biomarkers are found in the blood/tissue and may be related to the status of the disease
and/or your reaction to the study drug(s).
During the surgery, the insufflation pressure that is being used, including any changes that
are made to the pressure, will be recorded. After the surgery has been completed, you will
receive either Sugammadex or neostigmine by vein until the effects of the NMB have been
reversed.
You will recover after surgery in the post-anesthesia care unit (PACU). At about 15, 45, and
90 minutes after your surgery, a PACU nurse will ask you about any shoulder pain you are
feeling and if so, how intense the pain is. Information about how long you stay in the
hospital after surgery and if you have any side effects after surgery (such as
nausea/vomiting or shoulder pain) will also be collected from your medical record.
Follow-Up:
After 30 days after you leave the hospital, you will be called by a member of the study staff
to ask how you are doing and if you have had any additional hospitalizations since leaving
the hospital. This phone call should last about 5-10 minutes.
Length of Study Participation:
Your participation in this study will be over after completing the 30-day follow up phone
call.
Inclusion Criteria:
1. Patients 65 years of age or older
2. Patients having robotic prostatectomy
3. Written informed consent
Exclusion Criteria:
1. Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
2. Patients with severe renal insufficiency, defined and confirmed by an estimated
creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
3. Patients with history of severe liver disease, defined as and confirmed by elevated
ALT and AST greater than 1.5 times the Upper Limit of Normal along with Albumin less
than 3 OR INR 1.5 or greater per institutional laboratory.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
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