Residual Curarization and Its Incidence at Tracheal Extubation (P08194) (RECITE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01318382

First received: March 17, 2011

Last updated: June 18, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 17, 2011
Last Updated Date	June 18, 2012
Start Date ^ICMJE	June 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 17, 2011)	Incidence of residual blockade (TOF ratio <0.9) at time of tracheal extubation. [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01318382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 17, 2011)	Incidence of residual blockade (TOF ratio <0.9) upon arrival to the post-anesthesia care unit (PACU [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ] Incidences of residual blockade at various TOF ratios (<0.6, ≥ 0.6 - <0.7, ≥ 0.7 - <0.8, ≥0.8 - <0.9) at tracheal extubation and upon arrival to the PACU [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Residual Curarization and Its Incidence at Tracheal Extubation (P08194)
Official Title ^ICMJE	Residual Curarization and Its Incidence at Tracheal Extubation
Brief Summary	This study will assess the residual blockade Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for subjects whose non-depolarizing-induced neuromuscular blockade is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.
Detailed Description	This is an observational cohort study with a device intervention to determine in which cohort the subject is falling in.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Anesthesia Recovery Period
Intervention ^ICMJE	Other: Abdominal surgery Participant with elective laparoscopic surgery or open abdominal surgery
Study Arm (s)	Experimental: Post-operative residual blockage Intervention: Other: Abdominal surgery
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	302
Completion Date	May 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Participant must be American Society of Anesthesia (ASA) class 1-3. Participant must be scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours. Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade. Extubation must occur in the operating room (OR). Exclusion Criteria: Surgery re-admission on the same hospital admission. Pre-established need for or expected to require post-operative mechanical ventilation. Conditions, surgical procedures or position that may interfere with the TOF-Watch SX® operation, calibration or accuracy. Administration of sugammadex (Bridion®) for reversal of neuromuscular blockade. Participation in any other clinical trial. member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial. Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01318382
Other Study ID Numbers ^ICMJE	P08194
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top