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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-

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03108989
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia Drug: Sugammadex Drug: Neostigmine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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-
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : July 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sugammadex group
After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
Drug: Sugammadex
After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.

Active Comparator: Neostigmine group
After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.
Drug: Neostigmine
After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.




Primary Outcome Measures :
  1. physiological domain of PQRS recovery [ Time Frame: 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 :
  1. overall PQRS recovery and recovery in the different domains of the PQRS [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108989


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03108989    
Other Study ID Numbers: 4-2015-0641
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents