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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.

Study Description
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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.

Condition or disease Intervention/treatment
Neuromuscular Blockade Other: Neuromuscular Blocking Agent (NMBA)

Study Design
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Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Cohort
Official Title: Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
Study Start Date : July 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Portuguese participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181349    
Other Study ID Numbers: P07535
First Posted: August 13, 2010    Key Record Dates
Results First Posted: April 2, 2012
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Merck Sharp & Dohme Corp.:
neuromuscular blockade; general anesthesia
Additional relevant MeSH terms:
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Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs