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This trial aims to compare the incidence of postoperative residual curarisation (PORC) and postoperative pulmonary complications (PPCs) in the SUG and NEO group by means of diaphragm ultrasonography and LUS, so as to conclude whether SUG can outperform NEO in preventing occurrence of PORC and PPCs.
The incidence of postoperative residual curarisation (PORC) is about 2%-64% worldwide, which may be an underling risk factor of postoperative pulmonary complications (PPCs), causing many undesirable effects on patients. Thus, reversal drugs of neuromuscular blocking agents (NMBAs) such as neostigmine (NEO) and sugammadex (SUG) have been administrated, and SUG maybe perform better in preventing PORC. Different supplementary methods to help identify PORC or PPCs have also been reported, such as adductor of pollicis acceleromyography and lung ultrasound (LUS). Recently, diaphragm ultrasonography has been used to evaluate PORC, as a novel approach.In this prospective, double-blind, randomized controlled trial, we will enroll 414 patients of American Society of Anesthesiologists physical status I-III, aged over 60 years, who will be scheduled to undergo arthroplasty surgery under general anesthesia. Participants will be randomized into NEO and SUG group receiving neostigmine and sugammadex as reversal drug respectively. The primary outcomes will be the incidence of PPCs in NEO and SUG group respectively. The secondary outcome is the incidence of PORC in the two groups.We hypothesize that: 1) the incidence of PPCs is lower after reversal with SUG than with NEO, 2) using the method of diaphragm ultrasonography, the incidence PORC is lower after reversal with SUG than with NEO, 3) the incidence of PPCs can be predicted by LUS and by evaluating whether there is PORC through diaphragmatic ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUG group | Experimental | sugammadex as reversal drugs |
|
| NEO group | No Intervention | neostigmine as reversal drugs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sugammadex as reversal drugs | Drug | use sugammadex to reverse neuromuscular blockade |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative pulmonary complications | incidence of postoperative pulmonary complications | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography | Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography(LUS) | preoperatively, 10min and 30min after extubation for diaphragm ultrasonography and LUS |
| Measure | Description | Time Frame |
|---|---|---|
| sedation score | sedation score OAAS | 10min and 30min after extubation |
| duration of hospitalization | duration of hospitalization | 30 days after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHEN YING | Contact | +8619801103037 | ddlondon@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ZHANG YUGUAN, doctoral | Peking Union Medical College Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35526047 | Derived | Zhang YG, Chen Y, Zhang YL, Yi J. Comparison of the effects of neostigmine and sugammadex on postoperative residual curarization and postoperative pulmonary complications by means of diaphragm and lung ultrasonography: a study protocol for prospective double-blind randomized controlled trial. Trials. 2022 May 7;23(1):376. doi: 10.1186/s13063-022-06328-3. |
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| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| dosage of intravenous and inhaling sedative drug, analgesia drug, NMBAs | dosage of intravenous and inhaling sedative drug, analgesia drug, NMBAs | 30 days after surgery |
| duration of surgery and anesthesia | duration of surgery and anesthesia | 30 days after surgery |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |