Controlled Sedoanalgesia in External DCR Surgery

Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery

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.

Study Overview

• Status: Completed
• Conditions: Sedation; General Anesthesia; Dacryocystorhinostomy
• Intervention / Treatment: Procedure: Controlled sedoanalgesia

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ni̇lüfer
    • Bursa, Ni̇lüfer, Turkey, 16000
      • Bursa Uludag Universitesi Tip Fakultesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Turkish Society of Anesthesiology and Reanimation

Publications and helpful links

General Publications

• Ciftci F, Pocan S, Karadayi K, Gulecek O. Local versus general anesthesia for external dacryocystorhinostomy in young patients. Ophthalmic Plast Reconstr Surg. 2005 May;21(3):201-6. doi: 10.1097/01.iop.0000163317.73873.c9.
• Tuladhar S, Adhikari S, Bhattarai BK. Effectiveness of sedation in dacryocystorhinostomy surgery. Nepal J Ophthalmol. 2009 Jan-Jun;1(1):25-31. doi: 10.3126/nepjoph.v1i1.3670.
• Scawn RL, Allen MJ, Rose GE, Verity DH. Randomised, masked study of local anaesthesia administered prior to external dacryocystorhinostomy under general anaesthesia. Eye (Lond). 2019 Mar;33(3):374-379. doi: 10.1038/s41433-018-0201-5. Epub 2018 Sep 18.
• Eghbal MH, Sahmeddini MA. Comparison larygeal mask airway with the endotracheal tube for the external dacryocystorhionostomy surgery. A randomized clinical trial. Middle East J Anaesthesiol. 2013 Oct;22(3):283-8.
• Kersey JP, Sleep T, Hodgkins PR. Ocular perforation associated with local anaesthetic for dacryocystorhinostomy. Eye (Lond). 2001 Oct;15(Pt 5):671-2. doi: 10.1038/eye.2001.213. No abstract available.
• Apan A, Doganci N, Ergan A, Buyukkocak U. Bispectral index-guided intraoperative sedation with dexmedetomidine and midazolam infusion in outpatient cataract surgery. Minerva Anestesiol. 2009 May;75(5):239-44. Epub 2008 Dec 17.
• Harissi-Dagher M, Boulos P, Hardy I, Guay J. Comparison of anesthetic and surgical outcomes of dacryocystorhinostomy using loco-regional versus general anesthesia. Digit J Ophthalmol. 2008 Jan 1;14:1-6. doi: 10.5693/djo.01.2008.001. eCollection 2008.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): February 7, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: uludaganesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No