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

Not Applicable

Completed

• Conditions: Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT03108989
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-08
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-11
• Primary Completion: 2017-07-25
• Study Completion: 2017-07-25
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex group	Sugammadex	After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
Neostigmine group	Neostigmine	After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.

Primary Outcome Measures

Name	Time	Method
physiological domain of PQRS recovery	at 40 min after the end of surgery	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.

Secondary Outcome Measures

Name	Time	Method
overall PQRS recovery and recovery in the different domains of the PQRS	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.	at 15 min, 40 min , 1 day after the end of surgery.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine; 🇰🇷 Seoul, Korea, Republic of