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Completed

NCT Number: NCT01181349

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

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Blocking Agent (NMBA)

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal

Acronym: INSPIRE

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2010
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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