Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General AnesthesiaNCT03108989
Comparison the Postoperative Quality of Recovery Between Neostigmine and Sugammadex in Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia -Randomized Controlled Trial-
A study testing Sugammadex and Neostigmine in people with Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia
- What is being tested?
- Sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2017to 25 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged over 60 years who are scheduled for trans pars plana vitrectomy with general anesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Seoul, 03722
About this study
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.
Read more
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
- Being tested
- Sugammadex, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
NeostigmineDrug
After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex group | Experimental | After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade. Receives: Drug: Sugammadex |
| Neostigmine group | Active comparator | After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade. Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 40 min after the end of surgery
Secondary outcomes (1)
overall PQRS recovery and recovery in the different domains of the PQRS
at 15 min, 40 min , 1 day after the end of surgery.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start8 Feb 2017
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108989
- Sponsor's protocol ID
- 4-2015-0641
- Status last verified
- Nov 2017
- First submitted
- 6 Apr 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30939422
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-
- ClinicalTrials.gov ID
- NCT03108989
- Acronym / sponsor ID
- 4-2015-0641
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex group | Experimental | Drug: SugammadexAfter the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade. |
| Neostigmine group | Active comparator | Drug: NeostigmineAfter the end of surgery, neostigmine will be administered to reverse neuromuscular blockade. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged over 60 years who are scheduled for trans pars plana vitrectomy with general anesthesia
Key exclusion criteria (6 listed)
- Neuromuscular disease
- History of malignant hyperthermia
- Significant renal or hepatic dysfunction
- Allergy to sugammadex or rocuronium
- BMI > 30kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAfter the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade. | Drug | Sugammadex group |
| NeostigmineAfter the end of surgery, neostigmine will be administered to reverse neuromuscular blockade. | Drug | Neostigmine group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 30939422Kim 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological domain of PQRS recovery (time frame: at 40 min after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.