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Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed) (INSPIRE)

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ClinicalTrials.gov Identifier: NCT01181349
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : April 2, 2012
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date July 23, 2010
First Posted Date August 13, 2010
Results First Submitted Date February 29, 2012
Results First Posted Date April 2, 2012
Last Update Posted Date October 14, 2015
Study Start Date July 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 29, 2012)
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival [ Time Frame: Upon arrival in the PACU ]
The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio <0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).
Original Primary Outcome Measures
 (submitted: August 12, 2010)
Incidence of postoperative residual neuromuscular blockade, defined by a train-of-four (TOF) ratio < 0.9, at PACU arrival. [ Time Frame: Measure will be assessed on the day of first study site initiation (eg, study start, 07-2010) and will end after the primary outcome measure LSLV (09, 2010, anticipated). ]
The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was to be assessed in study participants upon arrival in the PACU, after their respective surgical procedures have been completed. TOF ratios of < 0.9 or ≥ 0.9 are to be assessed, indicating incomplete or complete neuromuscular recovery following general anesthesia treatment, respectively.
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2012)
  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents [ Time Frame: From start of surgery through PACU arrival ]
    Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.
  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane [ Time Frame: From start of surgery through PACU arrival ]
    Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.
  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents [ Time Frame: From end of surgery through PACU arrival, an expected average of 10 minutes ]
    Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.
  • Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events [ Time Frame: From end of surgery through hospital discharge, an expected average of 6 days ]
Original Secondary Outcome Measures
 (submitted: August 12, 2010)
Association between comorbidities, administered medication and the TOF ratio at PACU arrival. [ Time Frame: Measure will be assessed on the day of first study site initiation (eg, study start, 07-2010) and will end after the primary outcome measure LSLV (09- 2010, anticipated). ]
Potential associations among comorbidities, anesthesia drug(s) administered and the incomplete or complete recovery from neuromuscular blockade will be assessed using the Chi-square test or Fisher's Exact Test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed)
Official Title Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
Brief Summary This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult Portuguese participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents
Condition Neuromuscular Blockade
Intervention Other: Neuromuscular Blocking Agent (NMBA)
While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.
Study Groups/Cohorts
  • P07535 study participants with a TOF ratio <0.9
    Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio <0.9 at PACU arrival.
    Intervention: Other: Neuromuscular Blocking Agent (NMBA)
  • P07535 study participants with a TOF ratio ≥0.9
    Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio ≥0.9 at PACU arrival.
    Intervention: Other: Neuromuscular Blocking Agent (NMBA)
Publications * Esteves S, Martins M, Barros F, Barros F, Canas M, Vitor P, Seabra M, Castro MM, Bastardo I. Incidence of postoperative residual neuromuscular blockade in the postanaesthesia care unit: an observational multicentre study in Portugal. Eur J Anaesthesiol. 2013 May;30(5):243-9. doi: 10.1097/EJA.0b013e32835dccd7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2010)
350
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Informed consent signed
  • Admission for elective surgery
  • Administration of nondepolarizing NMBAs during surgery

Exclusion Criteria:

  • Admission for emergency surgery
  • Reoperation on the same hospital admission
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Portugal
 
Administrative Information
NCT Number NCT01181349
Other Study ID Numbers P07535
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 Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015