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

NCT03108989 | Completed

• 1 other identifier: 4-2015-0641
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Sugammadex group

EXPERIMENTAL

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

Drug: Sugammadex

Neostigmine group

ACTIVE COMPARATOR

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

Drug: Neostigmine

Interventions

Sugammadex DRUG

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

Sugammadex group

Neostigmine DRUG

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

Neostigmine group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged over 60 years who are scheduled for trans pars plana vitrectomy with general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30939422 DERIVED

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 11, 2017
• Study Start: February 8, 2017
• Primary Completion: July 25, 2017
• Study Completion: July 25, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)