Clinical trial NCT03108989: Comparison the Postoperative Quality of Recovery Between Neostigmine and Sugammadex in Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia -Randomized Controlled Trial-
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: physiological domain of PQRS recovery
timeFrame: at 40 min after the end of surgery
Secondary outcomes:
measure: overall PQRS recovery and recovery in the different domains of the PQRS
timeFrame: 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.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
References:
citation: Kim NY, Koh JC, Lee KY, Kim SS, Hong JH, Nam HJ, Bai SJ. Influence of reversal of neuromuscular blockade with sugammadex or neostigmine on postoperative quality of recovery following a single bolus dose of rocuronium: A prospective, randomized, double-blinded, controlled study. J Clin Anesth. 2019 Nov;57:97-102. doi: 10.1016/j.jclinane.2019.02.014. Epub 2019 Mar 30.