Clinical Trials Logo
  1. Home
  2. Neuromuscular Blockade
  3. NCT00535496

Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)

Neuromuscular Blockade Clinical Trial

Official title:
Comparison of the T4/T1 Ratio Measured by Means of the TOF Watch® SX With the Reappearance of T4 Measured by Means of a Peripheral Nerve Stimulator in Adult Subjects Receiving 4.0 mg.Kg-1 Sugammadex at 15 Minutes After Rocuronium

Clinical Trial Summary

The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last maintenance dose of 0.15 mg/kg rocuronium.

Clinical Trial Description

The TOF-Watch® SX has been used for neuromuscular monitoring in all

clinical trials with sugammadex. In clinical practice however, a PNS is commonly

used in many hospitals worldwide. A disadvantage of a PNS is that it is not objective monitoring like the TOF-Watch® SX, and it can detect only the number of twitches. In this trial, the relationship between the time to reappearance of T4 using PNS (i.e. Ministim® model MS-IV) and the time to recovery of the T4/T1 ratio to 0.9 using the TOF-Watch® SX was determined after a dose of 4.0 mg/kg sugammadex was administered 15 minutes after the last dose of rocuronium. Determining this relationship will enable the provision of advice on when it is safe to extubate participants after administration of 4.0 mg/kg sugammadex for reversing neuromuscular block while using a PNS. The time to reappearance of T4 was assessed by a blinded PNS-assessor. This assessor was blinded for the dose of sugammadex used and for the TOF results measured with the TOF-Watch® SX. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00535496
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date September 2007
Completion date February 2008
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05558969 - The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex N/A
Completed NCT03168308 - Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients Phase 4
Not yet recruiting NCT03978780 - Erector Spinae Block vs. Placebo Block Study N/A
Completed NCT02912039 - Electromyographic Assessment of the TetraGraph in Normal Volunteers
Completed NCT02892045 - Mindray Neuromuscular Transmission Transducer
Completed NCT03427385 - Minimum Local Anesthetic Dose for Adductor Canal Block N/A
Completed NCT01450813 - The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy N/A
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Not yet recruiting NCT05993390 - Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients N/A
Recruiting NCT04609410 - Bleeding in Laparoscopic Liver Surgery N/A
Terminated NCT03649672 - The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor N/A
Completed NCT05687253 - Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery Phase 2
Completed NCT05474638 - Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery N/A
Completed NCT05120999 - Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
Completed NCT03608436 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery Phase 4
Completed NCT03572413 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. Phase 4
Recruiting NCT02930629 - Residual Block in Postoperative Anaesthetic Care Unit N/A
Completed NCT02932254 - Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex Phase 4
Completed NCT01828385 - Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex Phase 4
Completed NCT01809886 - Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial Phase 3