Postoperative Sugammadex After COVID-19

NCT05817019 | Unknown Phase 4 DMC

• 1 other identifier: 2023AS0079
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Researcher want to compare and evaluate the effect of sugammadex on postoperative recovery, with a focus on the occurrence of postoperative urinary dysfunction, in patients who have undergone regular abdominal surgery within a year of being infected with and treated for COVID-19. Post COVID-19 condition is a new and poorly understood clinical syndrome with potentially significant and life-altering consequences. Recent studies suggest that patients who have recovered from COVID-19 may experience autonomic dysfunction and be at risk for autonomic dysregulation/syndrome. In most patients undergoing general anesthesia, neuromuscular blockers are used, and their residual effects delay the recovery of autonomic function after surgery, leading to problems such as worsening bladder and bowel function. Therefore, reversal agents are used to aid in postoperative muscle recovery, with sugammadex and neostigmine being commonly used in clinical practice. While sugammadex is generally expected to result in faster postoperative recovery, limited reports exist on its effectiveness in patients who have recovered from COVID-19. This study aims to verify whether sugammadex is more effective than neostigmine in aiding the recovery of bowel and pulmonary function after surgery in patients who have recovered from COVID-19.

Conditions

General Anesthesia; COVID-19

Keywords

COVID-19; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• urinary retention incidence

  urinary retention incidence

  postoperative 1 hour

Secondary Outcomes (12)

• surgery time and anesthesia time

  perioperative period

• recovery time after anesthesia

  postoperative period, within 1 hour

• intraoperative blood loss

  perioperative period

• perioperative vital signs

  perioperative period

• additional sugammadex administration

  postoperative period, within 1 hour

Study Arms (2)

Sugammadex

EXPERIMENTAL

sugammadex 2mg/kg

Drug: Sugammadex Sodium

Neostigmine

ACTIVE COMPARATOR

neostigmine 50µg/kg + glycopyrollate 0.01mg/kg

Drug: neostigmine 50µg/kg + glycopyrollate 0.01mg/kg

Interventions

Sugammadex Sodium DRUG

Sugammadex Sodium 2mg/kg when TOF \>= 2, postoperative period

Also known as: Bridion

Sugammadex

neostigmine 50µg/kg + glycopyrollate 0.01mg/kg DRUG

neostigmine 50µg/kg + glycopyrollate 0.01mg/kg when TOF \>= 2, postoperative period

Also known as: neostigmine

Neostigmine

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 19 and 70 Male and Female All ethnicity Patients who are scheduled to take non-emergency abdominal surgery under general anesthesia.
• Patients who had the diagnosis of covid-19 by PCR, hospitalized, and applied O2 supplement therapy.
• ASA classification ≤ 3 Patients who had Covid-19 PCR positive within 1 year Patients who had hospitalized by Covid-19, followed by O2 therapy (nasal prong, continuous positive airway pressure (CPAP), ventilator etc.) Patients who hospitalized more than 48 hours after surgery. Patients who had a surgery for more than 1 hour.

Sponsors & Collaborators

• Korea University Ansan Hospital: lead

MeSH Terms

Conditions

COVID-19; Postoperative Complications

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Too Jae Min, M.D., Ph.D.

  Korea University Ansan Hospital

  STUDY CHAIR

Central Study Contacts

Too Jae Min, M.D., Ph.D.

CONTACT

82-10-7296-0353; minware2@nate.com

Sang Min Yoon, M.D.

CONTACT

82-10-8805-8619; ekha00041@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The neuromuscular reversal agent is received and prepared in advance by a separate medical staff (a separate anesthesiologist who does not participate in the patient's anesthesia), and the corresponding prescription order is made separately when the patient leaves the recovery room. Since it is diluted with physiological saline and prepared in a total amount of 5cc, the patient and the patient's anesthetist do not know about the drug until they leave the recovery room (double-blinded).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A double-blind, randomized, parallel design study

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 18, 2023
• Study Start: April 20, 2023
• Primary Completion: December 25, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share