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

NCT ID: NCT01181349

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-11-30

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.

Conditions

Neuromuscular Blockade

Study Design

• Observational Model Type: COHORT

Study Groups

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.

Neuromuscular Blocking Agent (NMBA)

Intervention Type: 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.

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.

Neuromuscular Blocking Agent (NMBA)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 23344123 (View on PubMed)

Other Identifiers

P07535

Identifier Type: -

Identifier Source: org_study_id