Clinical Trials Logo

Clinical Trial Summary

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) during sevoflurane anesthesia for Caucasian participants.


Clinical Trial Description

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial P05971 was conducted in Europe and set up to establish the dose response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were to be evaluated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00552617
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 2
Start date September 20, 2005
Completion date August 31, 2006

See also
  Status Clinical Trial Phase
Recruiting NCT06063798 - Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery N/A
Not yet recruiting NCT05035069 - Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR Phase 4
Completed NCT03861364 - Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose. Phase 4
Completed NCT02711280 - The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children N/A
Completed NCT01199471 - Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane N/A
Completed NCT00917033 - Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy Phase 4
Completed NCT00391885 - Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy Phase 4
Completed NCT03705026 - Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
Completed NCT00552929 - A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974) Phase 2
Completed NCT00298831 - Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023) Phase 3
Completed NCT00475215 - Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017) Phase 3
Recruiting NCT03943745 - EEG Changes During Induction of Propofol Anesthesia
Completed NCT03697642 - Nasopharyngeal Airway Guide Nasogastric Tube Placement N/A
Completed NCT04595591 - Observation of Propofol Titration at Different Speeds N/A
Not yet recruiting NCT05841316 - The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
Completed NCT04532502 - Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT06205212 - High-flow Nasal Oxygenation During Preoxygenation and Atelectasis N/A
Completed NCT00379613 - Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942) Phase 2
Completed NCT03841890 - The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure N/A