Comparison the Postoperative Quality of Recovery Between Neostigmine and Sugammadex in Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia -Randomized Controlled Trial-

Study Overview
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Brief Summary
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Sugammadex has been approved as the first targeted reversal binding agent providing predictable and complete reversal of neuromuscular blockade induced by rocuronium or vecuronium, and achieving so with a favourable safety profile. Its benefits over traditional acetylcholinesterase inhibitors have been widely demonstrated in many studies. The scope of such studies has been mostly related to the efficacy of NMB reversal and safety. However, the clinical use of sugammadex led some anaesthesiologists to observe that following the use of this agent, patients seemed to recover consciousness faster and look like they were feeling better. To present, there is little information on the effect of sugammadex on awakening from anaesthesia. The quality of postoperative recovery focused around patient-oriented endpoints has raised new interest as a measure of the quality of anaesthesia and a target towards which improvement can be directed. On the other hand, there is no single prospective study performed to address a possible effect of sugammadex on recovery from anaesthesia. The objective of this study was to compare the effect of sugammadex and neostigmine on the quality of postoperative recovery using the PQRS in elderly patients undergoing trans pars plana vitrectomy with general anesthesia

Official Title
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Comparison the Postoperative Quality of Recovery Between Neostigmine and Sugammadex in Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia -Randomized Controlled Trial-

Conditions
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Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged over 60 years who are scheduled for trans pars plana vitrectomy with general anesthesia Exclusion Criteria: Neuromuscular disease History of malignant hyperthermia Significant renal or hepatic dysfunction Allergy to sugammadex or rocuronium BMI > 30kg/m2 History of medication which affect neuromuscular blocker such as anti-convulsants, magnesium

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex group<br>After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade. | Drug: Sugammadex<br>* After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.<br>|
| Active Comparator: Neostigmine group<br>After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade. | Drug: Neostigmine<br>* After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physiological domain of PQRS recovery | The primary objective of the study was to assess the physiological domain of PQRS recovery from anesthesia for patients treated with neostigmine and those given sugammadex at 40 min after the end of surgery. Recovery was defined as return (or improvement from) baseline values. | at 40 min after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall PQRS recovery and recovery in the different domains of the PQRS | at 15 min, 40 min , 1 day after the end of surgery. | The secondary objective of the study was to compare the overall PQRS recovery and recovery in the different domains of the PQRS between neostigmine and sugammadex treated patients at 15 min , 40 min , 1 day after the end of surgery. |