Controlled Sedoanalgesia in External DCR Surgery

• Sponsor: Turkish Society of Anesthesiology and Reanimation (Other)
• Overall Status: Completed
• CT.gov ID: NCT05397301
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dacryocystorhinostomy; Sedation; General Anesthesia	Procedure: Controlled sedoanalgesia	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery
• Actual Study Start Date: Feb 7, 2020
• Actual Primary Completion Date: Feb 7, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. hemodynamic data [through surgery completion]

   blood pressure (mm/hg)

2. hemodynamic data [through surgery completion]

   heart rate (bpm)

3. hemodynamic data [through surgery completion]

   peripheral oxygen saturation (percent)

4. amount of bleeding [amount of bleeding calculated during surgery]

   the amount that bleeds into the aspirator and cottons during the surgery (ml)

Secondary Outcome Measures

1. postoperative complications [postoperatif 12 hour]

   pain

2. postoperative complications [postoperatif 12 hour]

   nause and vomiting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bursa Uludağ Üniversitesi Tip Fakültesi	Bursa	Ni̇lüfer	Turkey	16000

Sponsors and Collaborators

• Turkish Society of Anesthesiology and Reanimation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Apan A, Doganci N, Ergan A, Büyükkoçak 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.
• 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.
• 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.
• 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.
• Kersey JP, Sleep T, Hodgkins PR. Ocular perforation associated with local anaesthetic for dacryocystorhinostomy. Eye (Lond). 2001 Oct;15(Pt 5):671-2.
• 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.
• Tuladhar S, Adhikari S, Bhattarai BK. Effectiveness of sedation in dacryocystorhinostomy surgery. Nepal J Ophthalmol. 2009 Jan-Jun;1(1):25-31.

• Responsible Party: Turkish Society of Anesthesiology and Reanimation
• ClinicalTrials.gov Identifier: NCT05397301
• Other Study ID Numbers: uludaganesthesia
• First Posted: May 31, 2022
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 31, 2022