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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 31, 2014
Last verified: October 2014
  Purpose

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 Intervention
Neuromuscular Blockade
Other: Neuromuscular Blocking Agent (NMBA)

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 350
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181349     History of Changes
Other Study ID Numbers: P07535
Study First Received: July 23, 2010
Results First Received: February 29, 2012
Last Updated: October 31, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Merck Sharp & Dohme Corp.:
neuromuscular blockade; general anesthesia

Additional relevant MeSH terms:
Anesthetics
Neuromuscular Blocking Agents
Central Nervous System Agents
Central Nervous System Depressants
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014