An interventional study of Controlled sedoanalgesia in Dacryocystorhinostomy, Sedation and General Anesthesia, sponsored by Turkish Society of Anesthesiology and Reanimation. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Turkish Society of Anesthesiology and Reanimation · Not applicable, Interventional, and Treatment
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.
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.
Turkish Society of Anesthesiology and Reanimation is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sedoanalgesia was applied to the SA group
Procedure: Controlled sedoanalgesia
General anaesthesia was applied to the GA group
Procedure: Controlled sedoanalgesia
Controlled sedoanalgesia was applied with Bispectral index and dexmedetomidine
hemodynamic data
blood pressure (mm/hg)
Time frame: through surgery completion
hemodynamic data
heart rate (bpm)
Time frame: through surgery completion
hemodynamic data
peripheral oxygen saturation (percent)
Time frame: through surgery completion
amount of bleeding
the amount that bleeds into the aspirator and cottons during the surgery (ml)
Time frame: amount of bleeding calculated during surgery
postoperative complications
pain
Time frame: postoperatif 12 hour
postoperative complications
nause and vomiting
Time frame: postoperatif 12 hour
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Turkish Society of Anesthesiology and Reanimation