Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05397301
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2022-05-22
Brief Title:
Controlled Sedoanalgesia in External DCR Surgery
Sponsor:
Turkish Society of Anesthesiology and Reanimation
Organization:
Turkish Society of Anesthesiology and Reanimation
Study Overview
Official Title:
Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery
Status:
COMPLETED
Status Verified Date:
2022-05
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:
In our study we aim to compare general anesthesia and controlled sedoanalgesia methods in dacryocystorhinostomy DCR surgery in terms of hemodynamic data bleeding amount postoperative complications bleeding pain etc and anesthesia satisfaction in a prospective and randomized controlled manner
Detailed Description:
The patients were routinely monitored in the operating room in accordance with the standard protocol for elective surgeries and the preoperative findings blood pressure oxygen saturation cardiac rhythm peak heart rate were recorded
The decision of routine anesthesia was not interfered with The data of the patients were collected as GA group if general anesthesia was applied and SA group if sedoanalgesia was applied If general anesthesia was preferred anesthesia induction was performed with propofol fentanyl and rocuronium and sevoflurane was used for anesthesia maintenance Intravenous midazolam and dexmedetomidine infusions were administered to patients for whom sedoanalgesia was preferred The sedation level of these patients was followed up with the Ramsay sedation scale RSS and capnography monitoring was performed
Whether general anesthesia or sedoanalgesia was preferred local anesthesia was administered to all patients by the surgical team and intraoperative hemodynamic data mean arterial pressure heart rate oxygen saturation were followed
In addition to patients recruited for the study hemodynamic data after induction endotracheal intubation surgical incision and extubation were also recorded
Depth of anesthesia was monitored with a bispectral index monitor for both groups
Intraoperative bleeding amount canal damage etc Intraoperative complications such as In this study the pain levels of the patients were evaluated by visual pain score VAS at 0 and 30 minutes 1st 4th 8th and 12th hours Analgesic requirement postoperative nausea-vomiting and time duration of surgery length of hospital stay surgery-related complications ecchymosis epistaxis hematoma edema etc were recorded Patient and surgical team satisfaction of the patients was evaluated using a 5-point Likert Scale
The necessary measurements of the eyes and adnexa visual acuity meibomian gland measurement tear breakout time schirmer for which detailed eye examinations of the patients will be performed preoperatively and postoperatively on the 1st day 1st week 1st month 3rd month and 6th month tests intraocular pressure pupil width lens density corneal topography anterior and posterior segment Optical coherence tomography etc tear duct examination and lavage were performed The patients complaints about eye diseases were recorded As a result of the study in addition to local anesthesia in DCR surgery sedoanalgesia and general anesthesia methods were compared
The decision of routine anesthesia was not interfered with The data of the patients were collected as GA group if general anesthesia was applied and SA group if sedoanalgesia was applied If general anesthesia was preferred anesthesia induction was performed with propofol fentanyl and rocuronium and sevoflurane was used for anesthesia maintenance Intravenous midazolam and dexmedetomidine infusions were administered to patients for whom sedoanalgesia was preferred The sedation level of these patients was followed up with the Ramsay sedation scale RSS and capnography monitoring was performed
Whether general anesthesia or sedoanalgesia was preferred local anesthesia was administered to all patients by the surgical team and intraoperative hemodynamic data mean arterial pressure heart rate oxygen saturation were followed
In addition to patients recruited for the study hemodynamic data after induction endotracheal intubation surgical incision and extubation were also recorded
Depth of anesthesia was monitored with a bispectral index monitor for both groups
Intraoperative bleeding amount canal damage etc Intraoperative complications such as In this study the pain levels of the patients were evaluated by visual pain score VAS at 0 and 30 minutes 1st 4th 8th and 12th hours Analgesic requirement postoperative nausea-vomiting and time duration of surgery length of hospital stay surgery-related complications ecchymosis epistaxis hematoma edema etc were recorded Patient and surgical team satisfaction of the patients was evaluated using a 5-point Likert Scale
The necessary measurements of the eyes and adnexa visual acuity meibomian gland measurement tear breakout time schirmer for which detailed eye examinations of the patients will be performed preoperatively and postoperatively on the 1st day 1st week 1st month 3rd month and 6th month tests intraocular pressure pupil width lens density corneal topography anterior and posterior segment Optical coherence tomography etc tear duct examination and lavage were performed The patients complaints about eye diseases were recorded As a result of the study in addition to local anesthesia in DCR surgery sedoanalgesia and general anesthesia methods were compared
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