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Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone.
The objective of this study is to investigate whether there is a difference in the time to emergence from anesthesia and time to tracheal extubation in patients undergoing gynecologic and laparoscopic surgery under general anesthesia, comparing the concurrent administration of sevoflurane and remimazolam with the maintenance of anesthesia using sevoflurane alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane group, S group | No Intervention | The control group will maintain oxygen-air (O2-Air) at 2 L/min and adjust the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. | |
| Remimazolam/Sevoflurane group, RS group | Active Comparator | After tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | After tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60. |
| Measure | Description | Time Frame |
|---|---|---|
| time to emergence | A comparison will be made between the time to emergence from anesthesia in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery. | Immediate after the end of general anesthesia |
| time to tracheal extubation | A comparison will be made between the time to tracheal extubation in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery. | Immediate after the end of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| usage of vasopressors | usage of vasopressors during general anesthesia | During general anesthesia |
| severity of cough | severity of cough during tracheal extubation |
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Inclusion Criteria:
Adult patients aged 19 to 70 undergoing gynecologic and laparoscopic surgery under general anesthesia
Patients classified as American Society of Anesthesiologists (ASA) physical status classification I or II
Class I - Healthy patients without systemic disease Class II - Patients with mild systemic disease without functional limitation Class III - Patients with severe systemic disease that limits activity but is not incapacitating Class IV - Patients with incapacitating systemic disease that is a constant threat to life Class V - Moribund patients who are not expected to survive without the operation Class VI - Brain-dead patients for organ donation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Young Kim, MD, PhD | Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
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| immediate after the end of general anesthesia |
| time to discharge from the recovery room | time to discharge from the recovery room | immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more |
| postoperative pain scores | Visual analog scale (VAS) is going to be measured after entering the PACU. The VAS is a validated, subjective measure for acute and chronic pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | Immediate after entering the PACU, 15 minutes after entering the PACU |
| scores for postoperative nausea and vomiting | Postoperative nausea was evaluated by means of a classical VAS (0-10 cm) device and a 4-point VDS (verbal descriptive scale,0=no nausea, 1=mild, 2=moderate, 3=severe). | Immediate after entering the PACU, 15 minutes after entering the PACU |