Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385002
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-19
Brief Title:
Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence
Sponsor:
Pusan National University Yangsan Hospital
Organization:
Pusan National University Yangsan Hospital
Study Overview
Official Title:
Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence in Patients Undergoing Gynecological Laparoscopic Surgery Under General Anesthesia a Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Laparoscopic oophorectomy or hysterectomy is a commonly performed gynecological surgery and rapid recovery pain management prevention of postoperative nausea and vomiting are important factors determining early discharge and patient satisfaction With the recent emergence of enhanced recovery after surgery ERAS various clinical studies are being conducted to improve the quality of patient recovery through decisions regarding anesthesia methods and agents fluid administration prevention of nausea and vomiting and pain management during surgery
The method of inducing anesthesia with intravenous injection of anesthetic agents such as propofol followed by maintenance of anesthesia using inhalation anesthetics is generally performed as a method of general anesthesia Inhalation anesthetics commonly used for maintenance of anesthesia can be easily administered and removed via ventilation and they have the advantage of maintaining anesthesia depth relatively easily by monitoring parameters such as bispectral Index BIS and end-tidal gas concentration However it has the disadvantage of delaying recovery and increasing hospital stay due to postoperative nausea and vomiting and it decreases average arterial pressure proportionally to the dose due to systemic vasodilation
Remimazolam Byfavo Inj Hana Pharm Col Ltd Seoul Korea is a benzodiazepine-class drug used for induction and maintenance of general anesthesia and for sedation during procedures When remimazolam is used as a general anesthetic it is rapidly metabolized by enzymes in the liver compared to propofol resulting in a short context-sensitive half-life of 75 minutes and allowing for reversal with flumazenil Additionally it is known to induce fewer hemodynamic changes
There is research indicating that combining sevoflurane and propofol target plasma concentration 12 mcgmL for general anesthesia in adult patients reduces arousal excitement and provides rapid recovery However in general anesthesia using desflurane or remimazolam the time to tracheal extubation was longer in the remimazolam group Furthermore there is research suggesting that combining remimazolam with inhalation anesthesia during general anesthesia in pediatric patients can reduce the occurrence of emergence agitation after surgery but the time to emergence is longer However there is currently no research on the effects of combining sevoflurane and remimazolam for general anesthesia in adult patients on postoperative arousal and recovery
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
The method of inducing anesthesia with intravenous injection of anesthetic agents such as propofol followed by maintenance of anesthesia using inhalation anesthetics is generally performed as a method of general anesthesia Inhalation anesthetics commonly used for maintenance of anesthesia can be easily administered and removed via ventilation and they have the advantage of maintaining anesthesia depth relatively easily by monitoring parameters such as bispectral Index BIS and end-tidal gas concentration However it has the disadvantage of delaying recovery and increasing hospital stay due to postoperative nausea and vomiting and it decreases average arterial pressure proportionally to the dose due to systemic vasodilation
Remimazolam Byfavo Inj Hana Pharm Col Ltd Seoul Korea is a benzodiazepine-class drug used for induction and maintenance of general anesthesia and for sedation during procedures When remimazolam is used as a general anesthetic it is rapidly metabolized by enzymes in the liver compared to propofol resulting in a short context-sensitive half-life of 75 minutes and allowing for reversal with flumazenil Additionally it is known to induce fewer hemodynamic changes
There is research indicating that combining sevoflurane and propofol target plasma concentration 12 mcgmL for general anesthesia in adult patients reduces arousal excitement and provides rapid recovery However in general anesthesia using desflurane or remimazolam the time to tracheal extubation was longer in the remimazolam group Furthermore there is research suggesting that combining remimazolam with inhalation anesthesia during general anesthesia in pediatric patients can reduce the occurrence of emergence agitation after surgery but the time to emergence is longer However there is currently no research on the effects of combining sevoflurane and remimazolam for general anesthesia in adult patients on postoperative arousal and recovery
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None