Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pulmonary Complications
• Intervention / Treatment: Drug: sugammadex as reversal drugs

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.

• Study Type: Interventional
• Enrollment (Anticipated): 414
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CHEN YING; Phone Number: +8619801103037; Email: ddlondon@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I-III
2. Aged over 60 years
3. Anesthesia induction with rocuronium as NMBAs, maintenance with volatile sevoflurane
4. Scheduled to undertake joint surgery
5. Signed the informed consent form

Exclusion Criteria:

1. 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
2. Those with diaphragm insufficiency or massive pleural effusion
3. Women who are pregnant or nursing
4. Those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe
5. Declined to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SUG group; sugammadex as reversal drugs	Drug: sugammadex as reversal drugs; use sugammadex to reverse neuromuscular blockade
NO_INTERVENTION: NEO group; neostigmine as reversal drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative pulmonary complications	incidence of postoperative pulmonary complications	30 days after surgery

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation score	sedation score OAAS	10min and 30min after extubation
duration of hospitalization	duration of hospitalization	30 days after surgery
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: ZHANG YUGUAN, doctoral, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 31, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (ACTUAL): September 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: lung ultrasound; postoperative pulmonary complications; diaphragm ultrasonography; postoperative residual curarisation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: Diaphragm/Lung Ultrasound

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No