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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01181349
First received: July 23, 2010
Last updated: October 25, 2013
Last verified: October 2013

July 23, 2010
October 25, 2013
July 2010
November 2010   (final data collection date for primary outcome measure)
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival [ Time Frame: Upon arrival in the PACU ] [ Designated as safety issue: No ]
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).
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). ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01181349 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
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). ] [ Designated as safety issue: Yes ]
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.
Not Provided
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Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed)
Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal

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.

Not Provided
Observational
Observational Model: Cohort
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Non-Probability Sample

Adult Portuguese participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents

Neuromuscular Blockade
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.
  • 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)
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.
 
Completed
350
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01181349
P07535
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2013

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