DacryocystorhinostomyNCT05397301
Controlled Sedoanalgesia in External DCR Surgery
A study of Dacryocystorhinostomy and Sedation, run by Turkish Society of Anesthesiology and Reanimation at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dacryocystorhinostomy, Sedation, General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Cases with severe liver and kidney disease
- Those who refused to participate in the study
- They will have DCR surgery again
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludağ Üniversitesi Tip Fakültesi
Bursa, Ni̇lüfer, 16000
About this study
Official title: 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.
Read the 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.
- Conditions
- Dacryocystorhinostomy, Sedation, General Anesthesia
- Being tested
- Controlled sedoanalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled sedoanalgesiaProcedure or surgery
Controlled sedoanalgesia was applied with Bispectral index and dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| sedoanalgesia(SA group) | Active comparator | Sedoanalgesia was applied to the SA group Receives: Procedure: Controlled sedoanalgesia |
| general anaesthesia (GA group) | Active comparator | General anaesthesia was applied to the GA group Receives: Procedure: Controlled sedoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic data
blood pressure (mm/hg)
Measured: through surgery completion
hemodynamic data
heart rate (bpm)
Measured: through surgery completion
hemodynamic data
peripheral oxygen saturation (percent)
Measured: through surgery completion
amount of bleeding
the amount that bleeds into the aspirator and cottons during the surgery (ml)
Measured: amount of bleeding calculated during surgery
Secondary outcomes (2)
postoperative complications
pain
Measured: postoperatif 12 hour
postoperative complications
nause and vomiting
Measured: postoperatif 12 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start7 Feb 2020
- Primary completion7 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DacryocystorhinostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Anesthesiology and Reanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397301
- Sponsor's protocol ID
- uludaganesthesia
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15942495Tuladhar 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.
PubMed 21141018Scawn 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.
PubMed 30228368Eghbal 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.
PubMed 24649784Kersey 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.
PubMed 11702990Apan 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.
PubMed 19088698Harissi-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.
PubMed 29440968Saglam 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.
PubMed 41200122
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery
- ClinicalTrials.gov ID
- NCT05397301
- Acronym / sponsor ID
- uludaganesthesia
- Conditions
- Dacryocystorhinostomy, Sedation, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Turkish Society of Anesthesiology and ReanimationUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 7 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sedoanalgesia(SA group) | Active comparator | Procedure: Controlled sedoanalgesiaSedoanalgesia was applied to the SA group |
| general anaesthesia (GA group) | Active comparator | Procedure: Controlled sedoanalgesiaGeneral anaesthesia was applied to the GA group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled sedoanalgesiaControlled sedoanalgesia was applied with Bispectral index and dexmedetomidine | Procedure or surgery | general anaesthesia (GA group), sedoanalgesia(SA group) |
Primary outcome
hemodynamic data
Time frame: through surgery completion
blood pressure (mm/hg)
hemodynamic data
Time frame: through surgery completion
heart rate (bpm)
hemodynamic data
Time frame: through surgery completion
peripheral oxygen saturation (percent)
amount of bleeding
Time frame: amount of bleeding calculated during surgery
the amount that bleeds into the aspirator and cottons during the surgery (ml)
2 secondary outcomes
postoperative complications
Time frame: postoperatif 12 hour
postoperative complications
Time frame: postoperatif 12 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 15942495Ciftci 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.
- Background: PubMed 21141018Tuladhar 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.
- Background: PubMed 30228368Scawn 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.
- Background: PubMed 24649784Eghbal 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.
- Background: PubMed 11702990Kersey 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.
- Background: PubMed 19088698Apan 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.
- Background: PubMed 29440968Harissi-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.
- Derived from this study: PubMed 41200122Saglam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dacryocystorhinostomy and Sedation, run by Turkish Society of Anesthesiology and Reanimation at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic data (time frame: through surgery completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397301, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.