Postoperative Residual Curarization in Elderly Patients in Post-anesthesia Care Unit

Incidence of Postoperative Residual Curarization in Elderly Patients in the Post-anesthesia Care Unit, and Attitude and Awareness Questionnaire of Anesthesiologists

In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. In addition, we aimed to determine the incidence of PORC and factors associated with PORC in the recovery unit in elderly patients over 65 years of age who underwent surgery under general anesthesia using muscle relaxants with a prospective observational study.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Residual Curarization; Geriatrics
• Intervention / Treatment: Device: Train of four monitoring

Detailed Description

Postoperative residual curarization (PORC) after general anesthesia is an important complication that can cause adverse patient outcomes, including symptoms of airway obstruction, hypoxia, respiratory distress, muscle weakness, and dyspnea in the early and late stages.

Anticholinesterase agents are commonly used to reverse neuromuscular blockade. Even with the use of anticholinesterase, severe PORC can be seen. The use of anticholinesterases in elderly patients is controversial due to the high side-effect profile.

Sugammadex, which has been widely used with its approval by the United States Food and Drug Administration in 2015, is a reverse agent that acts through a different mechanism than traditional anticholinesterase agents (it is a cyclodextrin molecule that encapsulates steroid neuromuscular blockers). Compared to neostigmine, sugammadex reverses neuromuscular blockade faster and more reliably.

In this study, we aimed to determine the knowledge levels and approaches of anesthesiologists working in our clinic about postoperative residual curarization(PORC) in elderly patients with a questionnaire. In addition, we aimed to determine the incidence of PORC and factors associated with PORC in the recovery unit in elderly patients over 65 years of age who underwent surgery under general anesthesia using muscle relaxants with a prospective observational study.

The first phase of the study is a prospective observational study. Elderly patients (>65) who are scheduled to undergo elective surgery under general anesthesia and require intubation using muscle relaxants will be screened for PORC using Train of four monitor in the recovery unit.

In the second phase of the study, an online questionnaire with 15 questions will determine the knowledge and attitudes of anesthesiologists working in our clinic on the use of muscle relaxants and reversing agents in elderly patients, the use of neuromuscular monitoring and PORC.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Aysun Postaci; Phone Number: +90 5323520383; Email: aysunposta@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Recruiting
    • Ankara City Hospital
    • Contact: Aysun Postaci, As.Prof.Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Electively operated elderly patients >65 years old under general anesthesia

Description

Inclusion Criteria:

• age >65
• general anesthesia using non-depolarizing neuromuscular blocker

Exclusion Criteria:

• Patients with an ASA score greater than 3
• Those with contraindications to anesthetic drugs
• Those with neuromuscular, neurological and psychiatric diseases
• Patients in whom TOF monitoring is not possible in the ulnar nerve region
• Patients with advanced renal failure
• Patients with advanced hepatic insufficiency
• Those with decompensated heart failure
• Patients with BMI<18 and BMI>30
• Patients with uncontrolled hypertension, uncontrolled diabetes, pheochromocytoma, thyroid dysfunction
• Those who are incapable of reading and signing the consent form
• Patients who do not want to sign the consent form
• Patients deemed unsuitable by the investigator
• Those with chronic opioid use

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative residual curarization	The incidence of elderly patients that Train of Four(TOF) rate <0.9 in the postoperative care unit	through study completion( anticipated 5 months)

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Aysun Postaci, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative residual curarization; Geriatrics; Train of four
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: E1-21-1912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No