Phase 4
N=100
Neuromuscular Blockade on Shoulder Pain of Elderly
Malignant Neoplasms of Digestive Organs · Malignant Neoplasms of Female Genital Organs · Malignant Neoplasms of Male Genital Organs · Malignant Neoplasms of Urinary Tract
Bottom Line
View on ClinicalTrials.gov: NCT03210376 ↗Enrolled (actual)
100
Serious AEs
5.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Patients Who Reported Shoulder Pain — 12; 10 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Deep Neuromuscular Blockade (NMB) (Drug); Moderate Neuromuscular Blockade (NMB) (Drug); Sugammadex (Drug); Neostigmine (Drug); Pain Assessment (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Reported Shoulder Pain |
12; 10 | — |
| SECONDARY Cumulative Intraoperative Insufflation Pressure |
1995; 1581 | — |
| SECONDARY Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation |
110; 100 | — |
| SECONDARY Readiness to Discharge From the Post-Anesthesia Care Unit (PACU) |
2.92; 3.16; 2.82; 2.86; 2.12; 1.8 | — |
| SECONDARY Percentage of Participants With Nausea and/or Vomiting in PACU |
7; 6; 1; 0 | — |
| SECONDARY Surgical Exposure Grading |
25; 33; 19; 8; 5; 8 | — |
| SECONDARY Length of Hospital Stay |
2.2323; 1.8623 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients 65 years of age or older
- Patients having robotic prostatectomy
- Written informed consent
Exclusion Criteria
- Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
- Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
- 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.
Data sourced from ClinicalTrials.gov (NCT03210376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.