Trial Outcomes & Findings for Intraoperative Neuromuscular Blockade and Postoperative Atelectasis (NCT NCT03503565)

Results Overview

Atelectasis on Chest CT The lung area was delineated manually. To calculate atelectasis, a region of interest was laid out that encircled the dense part of the lung, excluding large vessels. For further analysis, the lung was divided into four categories: areas with densities ranging from -1000 to -900 Hounsfield units (HU) were classified as over-aerated, from -900 to -500 HU as normally aerated, from -500 to -100 HU as poorly aerated, and from -100 to +100 HU as non-aerated (atelectasis). The proportion of non-aerated lung tissue (-100 to +100 HU) was calculated by dividing the area of the region of interest with the whole lungs.

Recruitment status

COMPLETED

Target enrollment

118 participants

Primary outcome timeframe

1 day after the end of surgery

Results posted on

2021-08-20

Participant Flow

A patient in Deep block group declined to participate in the study after enrollment.

Participant milestones

Participant milestones
Measure	Moderate Block Group maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade	Deep Block Group maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade
Overall Study STARTED	59	58
Overall Study COMPLETED	59	58
Overall Study NOT COMPLETED	0	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	Moderate Block Group n=59 Participants maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade	Deep Block Group n=58 Participants maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade	Total n=117 Participants Total of all reporting groups
Age, Customized	64 years n=59 Participants	64 years n=58 Participants	64 years n=117 Participants
Sex: Female, Male Female	29 Participants n=59 Participants	43 Participants n=58 Participants	72 Participants n=117 Participants
Sex: Female, Male Male	30 Participants n=59 Participants	15 Participants n=58 Participants	45 Participants n=117 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Preoperative abnormal chest radiography Pleural effusion	0 Participants n=2 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography	8 Participants n=16 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography	8 Participants n=18 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography
Preoperative abnormal chest radiography Pneumothorax	2 Participants n=2 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography	4 Participants n=16 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography	6 Participants n=18 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography
Preoperative abnormal chest radiography Etc.(Pulmonary edema or infiltration, atelectasis, hemothrorax)	0 Participants n=2 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography	4 Participants n=16 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography	4 Participants n=18 Participants • Because the number of participants only counts the people who present abnormality on preoperative chest radiography

PRIMARY outcome

Timeframe: 1 day after the end of surgery

Atelectasis on Chest CT The lung area was delineated manually. To calculate atelectasis, a region of interest was laid out that encircled the dense part of the lung, excluding large vessels. For further analysis, the lung was divided into four categories: areas with densities ranging from -1000 to -900 Hounsfield units (HU) were classified as over-aerated, from -900 to -500 HU as normally aerated, from -500 to -100 HU as poorly aerated, and from -100 to +100 HU as non-aerated (atelectasis). The proportion of non-aerated lung tissue (-100 to +100 HU) was calculated by dividing the area of the region of interest with the whole lungs.

Outcome measures

Outcome measures
Measure	Moderate Block Group n=58 Participants maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade	Deep Block Group n=56 Participants maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery intraoperative neuromuscular blockade: The intensity of intraoperative neuromuscular blockade
Atelectasis Area on Chest CT	1.32 percentage of atelectasis volume Interval 0.47 to 3.2	1.41 percentage of atelectasis volume Interval 0.24 to 3.07

SECONDARY outcome

Timeframe: up to 7 days after the end of surgery

Acute respiratory distress syndrome can be defined as follows; Bilateral opacities not fully explained by effusions, lobar/lung collapse or nodules on chest radiograph or CT scan and Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic edema if no risk factor present and Partial pressure of pulmonary arterial oxygen / Oxygen friction \< 300 mmHg with positive end-expiratory pressure or continuous positive airway pressure of 5 cmH2O.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 7 days after the end of surgery

Pneumonia can be defined as follows; Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease): 1. new or progressive and persistent infiltrates 2. consolidation 3. cavitation; at least one of the following 1\) fever (\>38.0 C) with no other recognized cause 2) White blood cell count \< 4000/ml or \>12,000/ml 3) for adults \>70 yr, altered mental status with no other recognized cause; and at least two of the following 1. new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements 2. new onset or worsening cough, or dyspnea, or tachypnea 3. crackles or bronchial breath sounds 4. worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day after the end of surgery

Pleural effusion can be diagnosed on postoperative radiograph imaging.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 day after surgery completed

The number of patients showing desaturation (SpO2 \<95%) in room air.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 day after surgery completed

The number of patients requiring re-intubation due to postoperative respiratory difficulty.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: every 1 hour from the time of the tracheal intubation to the end of the skin closure.

Intraoperative lung compliance (ml/cmH2O) can be calculated with peak inspiratory pressure or plateau pressure, positive end-expiratory pressure and tidal volume.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: on the day of admission

Age in years, Gender, Weight in kilograms, Height in centimeters

Outcome measures

Outcome data not reported

Adverse Events

Moderate Block Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deep Block Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Hyungseok Seo

KYUNG HEE UNIVERSITY HOSPITAL AT GANGDONG

Phone: +821029306885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER