NCT05040490

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

August 25, 2021

Last Update Submit

September 3, 2021

Conditions

Postoperative Pulmonary Complications

Keywords

postoperative pulmonary complicationspostoperative residual curarisationlung ultrasounddiaphragm ultrasonography

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative pulmonary complications

    incidence of postoperative pulmonary complications

    30 days after surgery

Secondary Outcomes (1)

  • Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography

    preoperatively, 10min and 30min after extubation for diaphragm ultrasonography and LUS

Other Outcomes (4)

  • sedation score

    10min and 30min after extubation

  • duration of hospitalization

    30 days after surgery

  • dosage of intravenous and inhaling sedative drug, analgesia drug, NMBAs

    30 days after surgery

  • +1 more other outcomes

Study Arms (2)

SUG group

EXPERIMENTAL

sugammadex as reversal drugs

Drug: sugammadex as reversal drugs

NEO group

NO INTERVENTION

neostigmine as reversal drugs

Interventions

sugammadex as reversal drugsDRUG

use sugammadex to reverse neuromuscular blockade

SUG group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35526047DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • ZHANG YUGUAN, doctoral

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CHEN YING

CONTACT

+8619801103037ddlondon@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy director of surgery department

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 10, 2021

Study Start

August 31, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

September 10, 2021

Record last verified: 2021-09