Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01318382
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : May 22, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 17, 2011
First Posted Date  ICMJE March 18, 2011
Results First Submitted Date April 4, 2013
Results First Posted Date May 22, 2013
Last Update Posted Date May 9, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation [ Time Frame: Up to 1 minute prior to tracheal extubation ]
Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
Original 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 ]
Change History Complete list of historical versions of study NCT01318382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
  • Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU) [ Time Frame: Up to 2 minutes prior to PACU arrival ]
    Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
  • Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation [ Time Frame: Up to 1 minute prior to tracheal extubation ]
    Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.
  • Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU [ Time Frame: Up to 2 minutes prior to PACU arrival ]
    Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.
Original 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 ]
  • 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 ]
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 neuromuscular blockade (NMB) 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 participants whose non-depolarizing-induced NMB 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.
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Observation of Neuromuscular Block
Intervention  ICMJE Device: TOF-Watch SX® Monitoring of NMB
Participants will have the extent of NMB monitored by a TOF-Watch SX®.
Study Arms Experimental: TOF-Watch SX®
Participants who have undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
Intervention: Device: TOF-Watch SX® Monitoring of NMB
Publications * Fortier LP, McKeen D, Turner K, de Médicis É, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.

*   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
Actual Enrollment  ICMJE
 (submitted: June 15, 2012)
302
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2011)
300
Actual Study Completion Date May 2012
Actual 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT01318382
Other Study ID Numbers  ICMJE P08194
MK-8616-063 ( Other Identifier: Merck Protocol ID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP