Controlled Sedoanalgesia in External DCR Surgery

Study Overview
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Brief Summary
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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
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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 patient's 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.

Official Title
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Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery

Conditions
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Dacryocystorhinostomy, Sedation, General Anesthesia

Intervention / Treatment
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* Procedure: Controlled sedoanalgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary DCR surgery to be performed 18 years and older patients Having an American Society of Anesthesiology score of 1, 2, 3 Having approved and signed the informed consent form Exclusion Criteria: Patients younger than 18 years old Patients with an American Society of Anesthesiology score of 4 and above Patients who do not accept informed consent History of drug allergy and opioid tolerance Uncontrolled diabetes mellitus Coagulation disorder Cases with severe liver and kidney disease Those who refused to participate in the study They will have DCR surgery again

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sedoanalgesia(SA group)<br>Sedoanalgesia was applied to the SA group | Procedure: Controlled sedoanalgesia<br>* Controlled sedoanalgesia was applied with Bispectral index and dexmedetomidine<br>|
| Active Comparator: general anaesthesia (GA group)<br>General anaesthesia was applied to the GA group | Procedure: Controlled sedoanalgesia<br>* Controlled sedoanalgesia was applied with Bispectral index and dexmedetomidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic data | blood pressure (mm/hg) | through surgery completion | 
| hemodynamic data | heart rate (bpm) | through surgery completion | 
| hemodynamic data | peripheral oxygen saturation (percent) | through surgery completion | 
| amount of bleeding | the amount that bleeds into the aspirator and cottons during the surgery (ml) | amount of bleeding calculated during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | pain | postoperatif 12 hour | 
| postoperative complications | nause and vomiting | postoperatif 12 hour |