Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia Clinical Trial
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-
| Verified date | November 2017 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | July 25, 2017 |
| Est. primary completion date | July 25, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Anesthesiology and Pain Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | overall PQRS recovery and recovery in the different domains of the PQRS | at 15 min, 40 min , 1 day after the end of surgery. | 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. |