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Neuromuscular Blockade on Shoulder Pain of Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210376
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Results First Posted : October 7, 2019
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Digestive Organs Malignant Neoplasms of Female Genital Organs Malignant Neoplasms of Male Genital Organs Malignant Neoplasms of Urinary Tract Drug: Deep Neuromuscular Blockade (NMB) Drug: Moderate Neuromuscular Blockade (NMB) Drug: Sugammadex Drug: Neostigmine Behavioral: Pain Assessment Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : September 30, 2018
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sugammadex

Arm Intervention/treatment
Experimental: 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.

Drug: Deep Neuromuscular Blockade (NMB)
Deep Neuromuscular Blockade (NMB) given during surgery.

Drug: Sugammadex
4 mg/Kg, intravenously as a single bolus injection after surgery.

Behavioral: Pain Assessment
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Other Name: Survey

Experimental: 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.

Drug: Moderate Neuromuscular Blockade (NMB)
Moderate Neuromuscular Blockade (NMB) given during surgery.

Drug: Neostigmine
70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.

Behavioral: Pain Assessment
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Other Name: Survey




Primary Outcome Measures :
  1. Percentage of Patients Who Reported Shoulder Pain [ Time Frame: 30 days ]
    Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.


Secondary Outcome Measures :
  1. Cumulative Intraoperative Insufflation Pressure [ Time Frame: Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes) ]
    Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation.

  2. Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation [ Time Frame: Day 0 - Arrival time at PACU, an average of 3 minutes ]
    The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery. Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus.

  3. Readiness to Discharge From the Post-Anesthesia Care Unit (PACU) [ Time Frame: Assessed at 15, 45, 90 minutes during PACU stay. ]
    Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is<4 and no single category has a score of >1.Sedation.0:Patient is fully awake.1: Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate>10. 1: Snoring,10< RR<30. 2:R<10 or RR>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 ≥ 94%.1:90%≤SpO2<94%. 2:85%≤ SpO2 < 90%.3:SpO2 < 85%. Systolic Blood Pressure. 0:SBP ≥ 100mmHg.1:90mmHg≤SBP< 100mmHg.2:80mmHg≤SBP< 90mmHg or SBP>220mmHg.3:SBP<80mmHg.Heart Rate.0:50<HR≤100.1:100<HR≤120.2:40<HR≤ 50 or 120<HR≤130.3:HR<40 or HR>130.Pain at rest.0:No pain 1:Light pain.2:Moderate pain.3:Severe pain.Nausea.0:No nausea or vomiting.1:Light nausea or vomiting without previous nausea. 2:Moderate nausea and/or vomiting.3:Severe nausea and/or vomiting.

  4. Percentage of Participants With Nausea and/or Vomiting in PACU [ Time Frame: Day 0 - PACU stay, an average of 120 minutes ]
    Degree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU).

  5. Surgical Exposure Grading [ Time Frame: Day 0 - IntraOperative, from incision time to closing time(average 190 minutes) ]
  6. Length of Hospital Stay [ Time Frame: length of hospital stay(average of 3 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210376


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Wendell H. Williams III, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03210376    
Other Study ID Numbers: 2017-0046
NCI-2018-01176 ( Registry Identifier: NCI CTRP )
First Posted: July 6, 2017    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of digestive organs
Malignant neoplasms of female genital organs
Malignant neoplasms of male genital organs
Malignant neoplasms of urinary tract
Neuromuscular blockade
NMB
Sugammadex
Neostigmine
Pain Assessment
Survey
Additional relevant MeSH terms:
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Genital Neoplasms, Female
Genital Neoplasms, Male
Urologic Neoplasms
Shoulder Pain
Neoplasms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents