Phase 4 N=50 Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block
Neuromuscular Blockade
Primary: Urine Residual in PACU — 219; 222 ml
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=75 Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex
Diaphragmatic Dysfunction · Muscle Weakness · Muscle Fatigue
Primary: Electric Activity of the Diaphragm (Microvolts) — 3.7; 4.5; 3.2; 2.9 microvolt
Phase 3 N=62 Comparision of Different Dose of Neostigmine at Advanced Decurarization
Anesthesia
Primary: Mesure of the Train-of-four (TOF) — 3.8; 4.5; 11.5; 19 minute
Phase 4 N=163 Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex
Muscle Weakness
Primary: Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit. — 5 Participants
Phase 4 N=92 Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients
Neuromuscular Blockade
Primary: Number of Hypoxic Episodes — 1; 0 episode(s)
Phase 4 N=46 Sugammadex as Rescue Therapy
Neuromuscular Blockade
Primary: The Time Taken to Achieve a TOF Ratio of 0.9 After Administration Sugammadex — 3.13; 2.56; 2.33; 5.00 minutes
Phase 4 N=302 Residual Curarization and Its Incidence at Tracheal Extubation (P08194)
Observation of Neuromuscular Block
Primary: Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation — 56 percentage of participants
Phase 4 N=189 Best Management of Muscle Relaxation- Objective Monitoring
Residual Paralysis, Post Anesthesia
Primary: Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation — 0 Participants
Phase 2 N=49 Neuromuscular Blockade in Patients With Severe Renal Impairment
Neuromuscular Blockade · Renal Impairment
Primary: Time Until Complete Reversal of Neuromuscular Blockade — 14.8; 3.5 Minutes
Phase 4 N=79 Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
Microlaryngoscopy · Rigid Bronchoscopy
Primary: Time to Extubation After End of Procedure — 11.06; 10.36 Minutes
Phase 4 N=69 Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Neuromuscular Blockade · Anesthesia
Primary: Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent — 8; 3 minutes — p=<0.001
Phase 4 N=62 Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Incomplete Reversal of Neuromuscular Block
Primary: Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes — -700; -862 mL
Phase 4 N=40 Effect of Neuromuscular Blockade and Reversal on Breathing
Respiratory Insufficiency
Primary: Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response) — 0.66; 0.43; 0.54; 0.34 L/min/% desaturation
Phase 4 N=84 Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery
Kidney Transplant; Complications · Postoperative Residual Curarization · Postoperative Residual Weakness
Primary: Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU) — 22; 23 Participants
Phase 4 N=235 Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
Urinary Retention Postoperative · Laparoscopic Cholecystectomy · Neuromuscular Blockade
Primary: Number of Participants With Postoperative Urinary Retention (POUR) of Sugammadex and Neostigmine Groups — 20; 6 Participants
Phase 4 N=40 Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
Spine Surgery
Primary: Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade — 3.9; 26.29 Minutes
Phase 3 N=140 Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)
Anesthesia · Neuromuscular Blockade
Primary: Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9…
Phase 3 N=182 Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)
Anesthesia, General
Primary: Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium — 3.28; 55.50…
Phase 3 N=198 Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
Anesthesia, General
Primary: Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. — 1.62; 26.78; 4.47; 23.43 Minutes
Phase 4 N=100 Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile
Postoperative Respiratory Condition
Primary: Mean Lowest Saturation — 96.8; 93.3 percentage of oxygen saturation
Phase 3 N=100 Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)
Anesthesia
Primary: Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation — 1.02; 0.78 T4/T1 Ratio
Phase 4 N=58 Comparison of Time to Extubation Using Sugammadex or Neostigmine
Neuromuscular Blockade · Chronic Obstructive Pulmonary Disease
Primary: Number of Minutes to Return of Baseline Muscle Tone — 3.9; 12.9 minutes
Phase 4 N=60 Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
Underdosing of Other General Anesthetics
Primary: Reversal Time of Rocuronium — 124.9; 171.1 seconds
Phase 3 N=128 Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
Neuromuscular Blockade
Primary: Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 — 1.77; 14.80 minutes — p=<0.0001
Phase 3 N=1,008 Reevaluation Of Systemic Early Neuromuscular Blockade
Acute Respiratory Distress Syndrome
Primary: Hospital Mortality to Day 90 — 288; 289; 213; 216 Participants — p=0.93
Phase 4 N=288 Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
Neuromuscular Blockade
Primary: Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A] — 14.1; 18.8; 27.6; 26.9 hr*μg/mL
Phase 4 N=100 Sugammadex Titration in Cardiac Surgery Patients
Coronary Artery Disease · Valvular Heart Disease · Aorta Disease
Primary: Total Dose of Sugammadex Required to Produce a Train-of-four Ratio of >0.9, Categorized as Greater Than or Less Than the Manufacturers Recommended Dose Based on the…
Phase 3 N=154 Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
Surgical Procedures, Elective
Primary: Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry — 0; 33 participants…
Phase 4 N=80 Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Pre-eclampsia Aggravated
Primary: TOF 0.9 Achieving Time — 1.6; 2.1 minutes
Phase 4 N=108 Neuromuscular Blockade During Transurethral Resection of Bladder Cancer
Neuromuscular Blockade
Primary: Number of Participants Attaining a 5 (Optimal) Surgical Condition Score — 16; 38 Participants