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

Neuromuscular Blockade Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181349
• Other study ID #: P07535
• Status: Completed
• Phase: N/A
• First received: July 23, 2010
• Last updated: October 12, 2015
• Start date: July 2010
• Est. completion date: November 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival	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).	Upon arrival in the PACU	No
Secondary	Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents	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.	From start of surgery through PACU arrival	Yes
Secondary	Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane	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.	From start of surgery through PACU arrival	Yes
Secondary	Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents	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.	From end of surgery through PACU arrival, an expected average of 10 minutes	Yes
Secondary	Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events		From end of surgery through hospital discharge, an expected average of 6 days	Yes