Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2017-11-17
2020-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Deep Neuromuscular Blockade (NMB) + Sugammadex
Deep Neuromuscular Blockade (NMB) given during surgery.
Sugammadex intravenously as a single bolus injection after surgery.
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Deep Neuromuscular Blockade (NMB)
Deep Neuromuscular Blockade (NMB) given during surgery.
Sugammadex
4 mg/Kg, intravenously as a single bolus injection after surgery.
Pain Assessment
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Moderate Neuromuscular Blockade (NMB) + Neostigmine
Moderate Neuromuscular Blockade (NMB) given during surgery.
Neostigmine intravenously slowly over a period of at least 1 minute after surgery.
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Moderate Neuromuscular Blockade (NMB)
Moderate Neuromuscular Blockade (NMB) given during surgery.
Neostigmine
70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.
Pain Assessment
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deep Neuromuscular Blockade (NMB)
Deep Neuromuscular Blockade (NMB) given during surgery.
Moderate Neuromuscular Blockade (NMB)
Moderate Neuromuscular Blockade (NMB) given during surgery.
Sugammadex
4 mg/Kg, intravenously as a single bolus injection after surgery.
Neostigmine
70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.
Pain Assessment
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients having robotic prostatectomy
3. Written informed consent
Exclusion Criteria
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.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wendell H. Williams III, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Williams WH 3rd, Cata JP, Lasala JD, Navai N, Feng L, Gottumukkala V. Effect of reversal of deep neuromuscular block with sugammadex or moderate block by neostigmine on shoulder pain in elderly patients undergoing robotic prostatectomy. Br J Anaesth. 2020 Feb;124(2):164-172. doi: 10.1016/j.bja.2019.09.043. Epub 2019 Nov 26.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
University of Texas MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-01176
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0046
Identifier Type: -
Identifier Source: org_study_id