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

• Conditions: Postoperative Residual Curarization; Geriatrics

• Registration Number: NCT05051371
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-08-02
• Study Start: 2021-08-15
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-21
• Last Update Posted: 2021-09-21
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey