Trial Outcomes & Findings for Incidence of Postoperative Residual Neuromuscular Blockade in Portugal (NCT NCT03417804)

Results Overview

Percentage of patients arriving PACU with a TOF ratio \< 0.9 measured as average of 3 consecutive TOF stimulations

Recruitment status

COMPLETED

Target enrollment

366 participants

Primary outcome timeframe

No more than 10 minutes after operating room exit

Results posted on

2021-07-06

Participant Flow

Patients \> 18 years old submitted to surgery under general anesthesia with the use of non-depolarizing neuromuscular blocking agents from 10 public Portuguese hospitals

Participant milestones

Participant milestones
Measure	Patients Proposed for Elective Surgical Procedures A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
Overall Study STARTED	366
Overall Study COMPLETED	366
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Proposed for Elective Surgical Procedures n=366 Participants A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
Age, Continuous	59 years n=366 Participants
Sex: Female, Male Female	207 Participants n=366 Participants
Sex: Female, Male Male	159 Participants n=366 Participants
Region of Enrollment Portugal	366 participants n=366 Participants

PRIMARY outcome

Timeframe: No more than 10 minutes after operating room exit

Percentage of patients arriving PACU with a TOF ratio \< 0.9 measured as average of 3 consecutive TOF stimulations

Outcome measures

Outcome measures
Measure	Patients Proposed for Elective Surgical Procedures n=366 Participants A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals 20 patients out of 366 presented with TOFr\< 0.9 which represents an incidence of 5,5%
Percentage of Patients With Postoperative Residual Neuromuscular Blockade	20 Participants

SECONDARY outcome

Timeframe: no more than 10 minutes after operating room exit

Percentage of patients with severe postoperative residual neuromuscular blockade defined by a TOF ratio \< 0.7

Outcome measures

Outcome measures
Measure	Patients Proposed for Elective Surgical Procedures n=366 Participants A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals 20 patients out of 366 presented with TOFr\< 0.9 which represents an incidence of 5,5%
Percentage of Patients With Severe Residual Postoperative Neuromuscular Blockade	2 Participants

SECONDARY outcome

Timeframe: no more than 10 minutes after operating room exit

Association of postoperative residual blockade and the use of reversal agents (neostigmine, sugammadex or none)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: no more than 10 minutes after operating room exit

To evaluate the association of postoperative residual blockade and the use of intra-operative monitoring of neuromuscular blockade

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: no more than 10 minutes after operating room exit

To evaluate the association of postoperative residual blockade with co- morbidities and ASA status

Outcome measures

Outcome data not reported

Adverse Events

Patients Proposed for Elective Surgical Procedures

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients Proposed for Elective Surgical Procedures n=366 participants at risk A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
Respiratory, thoracic and mediastinal disorders Pulmunary thromboembolism	0.27% 1/366 • Number of events 1 • 1 day Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
Musculoskeletal and connective tissue disorders Severe residual neuromuscular blockade	0.27% 1/366 • Number of events 1 • 1 day Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research

Other adverse events

Other adverse events
Measure	Patients Proposed for Elective Surgical Procedures n=366 participants at risk A multicentre prospective observational study in adult patients undergoing different types of elective surgical procedures requiring general anaesthesia with non-depolarizing NMBAs was conducted between July 2018 and July 2019 at 10 public Portuguese hospitals
Respiratory, thoracic and mediastinal disorders Hypoxemia	2.5% 9/366 • Number of events 9 • 1 day Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
General disorders Sore throat	0.27% 1/366 • Number of events 1 • 1 day Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research

Additional Information

Dr. Simão Esteves

Centro Hospitalar do Porto

Phone: +351222077549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place