Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hana Pharm Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Adult patients undergoing elective thyroidectomy are randomly allocated to receive propofol-based TIVA (n=35) or remimazolam-based TIVA (n=35). The recovery profile including the time from the end of anesthetic administration to eye-opening, the time from the end of anesthetic administration to extubation, hemodynamic stability, stability of anesthetic depth, duration of post-anesthetic care stay, the incidence of postoperative nausea and vomiting during the first 24 hours, and the quality of recover 24 hours after surgery using the quality of recovery-15 was assessed by an investigator. The primary outcome is the time from the end of anesthetic administration to eye-opening.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remimazolam group | Experimental | In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil 0.2mg, is administered at the end of surgery. In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure. |
|
| propofol group | Active Comparator | In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam-based TIVA | Drug | In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Modified Aldrete score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27496519 | Background | 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. | |
| 37131126 | Derived | Lee HJ, Lee HB, Kim YJ, Cho HY, Kim WH, Seo JH. Comparison of the recovery profile of remimazolam with flumazenil and propofol anesthesia for open thyroidectomy. BMC Anesthesiol. 2023 May 2;23(1):147. doi: 10.1186/s12871-023-02104-1. |
Not provided
Not provided
Not provided
A prospective randomized single-blinded study
Not provided
Not provided
Patients will receive general anesthesia, therefore they cannot know their anesthetic agents.
Physicians involved in this study will investigate the outcomes.
|
| propofol-based TIVA | Drug | In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France). |
|
|
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 |
| length of post-anesthetic care unit stay | length of post-anesthetic care unit stay (minute) | immediately after discharge from the post-anesthetic care unit |
| 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 |
| 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 |
| Intraoperative hemodynamic stability | Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) | during the operation |
| Intraoperative anesthetic depth stability | Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) | during the operation |