NCT05397301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 22, 2022

Last Update Submit

May 25, 2022

Conditions

DacryocystorhinostomySedationGeneral Anesthesia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • postoperative complications

    postoperatif 12 hour

  • postoperative complications

    postoperatif 12 hour

Study Arms (2)

sedoanalgesia(SA group)

ACTIVE COMPARATOR

Sedoanalgesia was applied to the SA group

Procedure: Controlled sedoanalgesia

general anaesthesia (GA group)

ACTIVE COMPARATOR

General anaesthesia was applied to the GA group

Procedure: Controlled sedoanalgesia

Interventions

Controlled sedoanalgesiaPROCEDURE

Controlled sedoanalgesia was applied with Bispectral index and dexmedetomidine

general anaesthesia (GA group)sedoanalgesia(SA group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary DCR surgery to be performed
  • years and older patients
  • Having an American Society of Anesthesiology score of 1, 2, 3
  • Having approved and signed the informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludağ Üniversitesi Tip Fakültesi

Bursa, Ni̇lüfer, 16000, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 15942495BACKGROUND

  • 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.

    PMID: 21141018BACKGROUND

  • 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.

    PMID: 30228368BACKGROUND

  • 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.

    PMID: 24649784BACKGROUND

  • 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.

    PMID: 11702990BACKGROUND

  • 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.

    PMID: 19088698BACKGROUND

  • 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.

    PMID: 29440968BACKGROUND

  • Saglam U, Kivanc SA, Girgin NK. Comparison of Anesthetic and Surgical Outcomes Between General Anesthesia and Dexmedetomidine-Based Sedoanalgesia in Dacryocystorhinostomy Surgery With Bispectral Index Monitoring. Anesthesiol Res Pract. 2025 Nov 4;2025:6650312. doi: 10.1155/anrp/6650312. eCollection 2025.

    PMID: 41200122DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2022

First Posted

May 31, 2022

Study Start

February 7, 2020

Primary Completion

February 7, 2021

Study Completion

March 1, 2021

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)