Pusan National University Yangsan Hospital
Yangsan, South Korea
NCT Number: NCT06385002
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.
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Notify Me19 year–70 year
Female
Interventional
Not applicable
Yangsan, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Other names: Byfavo
Time frame: Immediate after the end of general anesthesia
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.
Time frame: Immediate after the end of general anesthesia
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.
Time frame: During general anesthesia
usage of vasopressors during general anesthesia
Time frame: immediate after the end of general anesthesia
severity of cough during tracheal extubation
Time frame: immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more
time to discharge from the recovery room
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
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').
Time frame: Immediate after entering the PACU, 15 minutes after entering the PACU
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).
Pusan National University Yangsan Hospital
Other
Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence in Patients Undergoing Gynecological Laparoscopic Surgery Under General Anesthesia: a Prospective Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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