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

Yonsei University

Status: Completed

Conditions: Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia

Treatments: Drug: Neostigmine; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT03108989

4-2015-0641

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Sugammadex group

Experimental group

Description:

After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.

Treatment:

Drug: Sugammadex

Neostigmine group

Active Comparator group

Description:

After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.

Treatment:

Drug: Neostigmine