Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography
Primary Purpose
Postoperative Pulmonary Complications
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sugammadex as reversal drugs
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pulmonary Complications focused on measuring postoperative pulmonary complications, postoperative residual curarisation, lung ultrasound, diaphragm ultrasonography
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-III
- Aged over 60 years
- Anesthesia induction with rocuronium as NMBAs, maintenance with volatile sevoflurane
- Scheduled to undertake joint surgery
- Signed the informed consent form
Exclusion Criteria:
- Those with a history of hepatic or renal disease, chronic or acute alcoholism, allergy or hypersensitivity to sugammadex or neostigmine, current medication with effects on the central nervous system, a history of dysfunction of neuromuscular system
- Those with diaphragm insufficiency or massive pleural effusion
- Women who are pregnant or nursing
- Those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe
- Declined to participate
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SUG group
NEO group
Arm Description
sugammadex as reversal drugs
neostigmine as reversal drugs
Outcomes
Primary Outcome Measures
incidence of postoperative pulmonary complications
incidence of postoperative pulmonary complications
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT05040490
First Posted
August 25, 2021
Last Updated
September 3, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05040490
Brief Title
Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography
Official Title
Comparison of the Effects of Neostigmine and Sugammadex on Postoperative Residual Curarization and Postoperative Pulmonary Complications Detected by Diaphragm and Lung Ultrasonography: A Study Protocol for Prospective Double-blind Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pulmonary Complications
Keywords
postoperative pulmonary complications, postoperative residual curarisation, lung ultrasound, diaphragm ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SUG group
Arm Type
Experimental
Arm Description
sugammadex as reversal drugs
Arm Title
NEO group
Arm Type
No Intervention
Arm Description
neostigmine as reversal drugs
Intervention Type
Drug
Intervention Name(s)
sugammadex as reversal drugs
Intervention Description
use sugammadex to reverse neuromuscular blockade
Primary Outcome Measure Information:
Title
incidence of postoperative pulmonary complications
Description
incidence of postoperative pulmonary complications
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography
Description
Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography(LUS)
Time Frame
preoperatively, 10min and 30min after extubation for diaphragm ultrasonography and LUS
Other Pre-specified Outcome Measures:
Title
sedation score
Description
sedation score OAAS
Time Frame
10min and 30min after extubation
Title
duration of hospitalization
Description
duration of hospitalization
Time Frame
30 days after surgery
Title
dosage of intravenous and inhaling sedative drug, analgesia drug, NMBAs
Description
dosage of intravenous and inhaling sedative drug, analgesia drug, NMBAs
Time Frame
30 days after surgery
Title
duration of surgery and anesthesia
Description
duration of surgery and anesthesia
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status I-III
Aged over 60 years
Anesthesia induction with rocuronium as NMBAs, maintenance with volatile sevoflurane
Scheduled to undertake joint surgery
Signed the informed consent form
Exclusion Criteria:
Those with a history of hepatic or renal disease, chronic or acute alcoholism, allergy or hypersensitivity to sugammadex or neostigmine, current medication with effects on the central nervous system, a history of dysfunction of neuromuscular system
Those with diaphragm insufficiency or massive pleural effusion
Women who are pregnant or nursing
Those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe
Declined to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHEN YING
Phone
+8619801103037
Email
ddlondon@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZHANG YUGUAN, doctoral
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
35526047
Citation
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.
Results Reference
derived
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Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography
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