Clinical trial · Interventional
Neuromuscular Blockade on Shoulder Pain of Elderly
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms of Digestive Organs | — | UNRESOLVED | — |
| Malignant Neoplasms of Female Genital Organs | — | UNRESOLVED | — |
| Malignant Neoplasms of Male Genital Organs | — | UNRESOLVED | — |
| Malignant Neoplasms of Urinary Tract | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep Neuromuscular Blockade (NMB) | Drug | — | UNRESOLVED |
| Moderate Neuromuscular Blockade (NMB) | Drug | — | UNRESOLVED |
| Neostigmine | Drug | — | UNRESOLVED |
| Pain Assessment | Behavioral | — | UNRESOLVED |
| Sugammadex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Deep Neuromuscular Blockade (NMB) + Sugammadex
- description
- 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.
- interventionNames
- Drug: Deep Neuromuscular Blockade (NMB)
- Drug: Sugammadex
- Behavioral: Pain Assessment
- type
- EXPERIMENTAL
- label
- Moderate Neuromuscular Blockade (NMB) + Neostigmine
- description
- 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.
- interventionNames
- Drug: Moderate Neuromuscular Blockade (NMB)
- Drug: Neostigmine
- Behavioral: Pain Assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWilliams 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. PMID 31780139