General Anesthesia Clinical Trial
Official title:
Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery
Verified date | May 2022 |
Source | Turkish Society of Anesthesiology and Reanimation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 1, 2021 |
Est. primary completion date | February 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bursa Uludag Üniversitesi Tip Fakültesi | Bursa | Ni?lüfer |
Lead Sponsor | Collaborator |
---|---|
Turkish Society of Anesthesiology and Reanimation |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Kersey JP, Sleep T, Hodgkins PR. Ocular perforation associated with local anaesthetic for dacryocystorhinostomy. Eye (Lond). 2001 Oct;15(Pt 5):671-2. — View Citation
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. — View Citation
Tuladhar S, Adhikari S, Bhattarai BK. Effectiveness of sedation in dacryocystorhinostomy surgery. Nepal J Ophthalmol. 2009 Jan-Jun;1(1):25-31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hemodynamic data | blood pressure (mm/hg) | through surgery completion | |
Primary | hemodynamic data | heart rate (bpm) | through surgery completion | |
Primary | hemodynamic data | peripheral oxygen saturation (percent) | through surgery completion | |
Primary | amount of bleeding | the amount that bleeds into the aspirator and cottons during the surgery (ml) | amount of bleeding calculated during surgery | |
Secondary | postoperative complications | pain | postoperatif 12 hour | |
Secondary | postoperative complications | nause and vomiting | postoperatif 12 hour |
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