Controlled Sedoanalgesia in External DCR Surgery

Not Applicable

Completed

• Conditions: General Anesthesia; Dacryocystorhinostomy; Sedation
• Interventions: Procedure: Controlled sedoanalgesia

• Registration Number: NCT05397301
• Lead Sponsor: Turkish Society of Anesthesiology and Reanimation

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 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.

Study Timeline

• Study Start: 2020-02-07
• Primary Completion: 2021-02-07
• Study Completion: 2021-03-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sedoanalgesia(SA group)	Controlled sedoanalgesia	Sedoanalgesia was applied to the SA group
general anaesthesia (GA group)	Controlled sedoanalgesia	General anaesthesia was applied to the GA group

Primary Outcome Measures

Name	Time	Method
amount of bleeding	amount of bleeding calculated during surgery	the amount that bleeds into the aspirator and cottons during the surgery (ml)
hemodynamic data	through surgery completion	peripheral oxygen saturation (percent)

Secondary Outcome Measures

Name	Time	Method
postoperative complications	postoperatif 12 hour	nause and vomiting

Trial Locations

Locations (1)

Bursa Uludağ Üniversitesi Tip Fakültesi; 🇹🇷 Bursa, Ni̇lüfer, Turkey