Anesthesia, Intravenous Clinical Trial
Official title:
Comparison of Recovery Profile After Total Intravenous Anesthesia Between Remimazolam With Flumazenil and Propofol in Patients Undergoing Thyroidectomy: A Single-blinded Randomized Controlled Trial
Verified date | May 2023 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective, randomized, single-blinded study is designed to compare the recovery profile between propofol-based total intravenous anesthesia (TIVA) and remimazolam-based TIVA in patients undergoing thyroidectomy. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery. We hypothesize that remimazolam-based TIVA antagonized by flumazenil can significantly shorten the time from the end of anesthetic administration to eye-opening compared to propofol-based TIVA.
Status | Completed |
Enrollment | 58 |
Est. completion date | September 11, 2022 |
Est. primary completion date | August 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients scheduled to undergo elective thyroidectomy under general anesthesia - American Society of Anesthesiologists (ASA)physical classification I-II - Willingness and ability to sign an informed consent document Exclusion Criteria: - American Society of Anesthesiologists (ASA)physical classification III or more - BMI > 40kg/m^2 - Allergies to anesthetic or analgesic medications (benzodiazepines, propofol, remifentanil, fentanyl citrate, rocuronium bromide, sugammadex, flumazenil) - Patients who receive mechanical ventilation morethan 2 hours after surgery - Patients who receive the following medications within 24 hours prior to general anesthetics: anxiolytics, antipsychotics, rifampicin, succinycholine, neostigmine, flumazenil, cyclosporin - Patients with galactose intolerance or Lapp Lactase deficiency or glucose-galactose malabsorption - Medical or psychological disease that can affect the treatment response |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Hana Pharm Co., Ltd. |
Korea, Republic of,
Wesolowski AM, Zaccagnino MP, Malapero RJ, Kaye AD, Urman RD. Remimazolam: Pharmacologic Considerations and Clinical Role in Anesthesiology. Pharmacotherapy. 2016 Sep;36(9):1021-7. doi: 10.1002/phar.1806. Epub 2016 Sep 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in eye opening time between the two groups | difference in eye opening time after stopping injection of anesthetics (From the end of anesthetic administration to the first eye opening) | Up to the first eye opening from stopping injection of anesthetics | |
Secondary | Difference in extubation time between the two groups | difference in extubation time after stopping injection of anesthetics (From the end of anesthetic administration to extubation) | Up to extubation from stopping injection of anesthetics | |
Secondary | Modified Aldrete score | Modified Aldrete score (0-10, higher scores mean a better outcome) measured when admit the post-anesthetic care unit | Within 5 minutes of arrival at the post-anesthetic care unit | |
Secondary | length of post-anesthetic care unit stay | length of post-anesthetic care unit stay (minute) | immediately after discharge from the post-anesthetic care unit | |
Secondary | Postoperative nausea and vomiting during the first 24 hours postoperatively | Incidence of postoperative nausea and vomiting during the first 24 hours postoperatively | during the first 24 hours postoperatively | |
Secondary | postoperative quality of recovery | quality of recovery measured by the Korean version of the Quality of Recovery-15 (QoR-15K, 0-150, higher scores mean a better outcome) | at 24 hours postoperatively | |
Secondary | Intraoperative hemodynamic stability | Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) | during the operation | |
Secondary | Intraoperative anesthetic depth stability | Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) | during the operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03861364 -
Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
|
Phase 4 | |
Not yet recruiting |
NCT06092684 -
The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery
|
Phase 3 | |
Not yet recruiting |
NCT04266535 -
TCI vs Manually Controlled Infusion of Propofol
|
||
Recruiting |
NCT03864094 -
Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.
|
Phase 4 | |
Not yet recruiting |
NCT06237101 -
Remifentanil Effect on Burst Suppression Ratio
|
N/A | |
Completed |
NCT03861377 -
Hemodynamics During Induction of General Anesthesia With Medium or Low Remifentanil Doses.
|
Phase 4 | |
Completed |
NCT02492282 -
Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System
|
Phase 3 | |
Completed |
NCT03661489 -
Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery
|
Phase 3 | |
Completed |
NCT02197858 -
Comparability of Invasive and Non-invasive Haemodynamic Monitoring
|
N/A | |
Recruiting |
NCT03428191 -
Target Effect-site Concentration of Remifentanil in Transperineal Prostate Puncture
|
N/A | |
Completed |
NCT02527083 -
Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
|
Phase 4 | |
Completed |
NCT01531491 -
Effects of Hypercapnia on Emergence From General Anesthesia Under Propofol
|
N/A | |
Recruiting |
NCT00378170 -
Laryngoscope Prototype Tested Against the Traditional Macintosh Blade
|
N/A | |
Completed |
NCT03614325 -
Virtual Reality in the Operating Room
|
N/A | |
Completed |
NCT02706431 -
Oxygenation by 100% Oxygen Via High Flow Nasal Cannula in Surgical Patients
|
N/A | |
Withdrawn |
NCT04586998 -
Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Exhaled Drug Monitor "Edmon"
|
N/A | |
Active, not recruiting |
NCT05343260 -
Impact of Anesthesia Maintenance Methods on 5-year Survival After Surgery
|
N/A | |
Completed |
NCT02660411 -
Impact of Anesthesia Maintenance Methods on Long-term Survival
|
N/A |