Clinical trial NCT05241054: Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation
Official title: Comparison of Local Anesthesia and Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient With Nasolacrimal Duct Obstruction
External Dacryocystorhinostomy Operation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bleeding is one of the important complications during Dacryocystorhinostomy, which dissatisfy ophthalmic surgeon, reduces surgical field visualization, and increases the duration of surgery Thus, the management of this complication is a great consideration during this operation. The aim of this study is to compare the efficacy of combined local and general anesthesia in a group of patients undergoing external dacryocystorhinostomy (DCR) operation versus the efficacy of general anesthesia with induced hypotensive anesthesia

Detailed description: Dacryocystorhinostomy or DCR is among the common oculoplastics surgeries performed for managing epiphora due to nasolacrimal duct obstruction. The main purpose of DCR surgery is to eliminate the obstruction and to accomplish normal tear. DCR is a procedure performed to drain the lacrimal sac in which lacrimal flow is diverted into the nasal cavity through an artificial opening made at the level of the lacrimal sac in cases of chronic dacryocystitis or symptomatic nasolacrimal duct obstruction not relieved by simple probing and stringing.

Dacryocystorhinostomy (DCR) operation can be performed externally or endoscopically. External DCR was first described by Toti and this procedure was modified with the use of flaps by many authors. It is the gold standard of treatment with a reported success rate of more than 90%.

Bleeding during dacryocystorhinostomy (DCR) is trivial, but because of the anatomical vessel variation and presence of tiny vessels in the field of DCR, it can obscure the surgical field and complicate the operation.

One of the effective approaches for controlling bleeding tendency during DCR is to reduce blood pressure in patients. Ideal hypotensive medications administered to reduce blood pressure should have specific features such as easy to administration, being with rapid onset and offset without side effects, rapid elimination without any toxic metabolites, and having a predictable and dose-dependent action. Nitroglycerine (TNG) is a direct vasodilator agent, especially in veins, and produces hypotension, and is preferred by clinicians because of rapid onset and offset time and easy titration.

Another mechanism for controlling bleeding is infiltrating the incision site by local anesthetic with admixed epinephrine to promote local vasoconstriction to decrease blood loss and prolong the duration of local anesthesia providing more time for analgesia.

In this study, the investigators will compare the efficacy of local versus induced hypotensive anesthesia in generally anesthetized patients undergoing external DCR operation on amount of blood loss, quality of the surgical field, intraoperative hemodynamics, and surgeon satisfaction

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II
* patients who are scheduled for external Dacryocystorhinostomy operation

Exclusion Criteria:

* Patient refusal.
* Patients with history for cerebrovascular.
* Patients with history for coronary insufficiency.
* Local skin infection at site of injection.
* Known hypersensitivity to the study drugs.
* Extremes of age.
* Patients with any type of arrhythmias.
* Hematological diseases.
* Bleeding abnormality
* Coagulation abnormality

Primary outcomes:
measure: Average category scale (ACS)
timeFrame: after 10 min of maintaining mean arterial blood pressure (MAP) at the desired range (55-65 mmHg)
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: procedure (basal reading and every 5 minutes till the end of anesthesia )
measure: Heart Rate (HR)
timeFrame: procedure (basal reading and every 5 minutes till the end of anesthesia)
measure: Postoperative visual analogue score (VAS)
timeFrame: up to 24 hours after the procedure
measure: Postoperative analgesics intake
timeFrame: up to 24 hours after the procedure
measure: Surgeon satisfaction
timeFrame: at the end of the procedure
measure: Nausea
timeFrame: up to 24 hours after the procedure
measure: Vomiting
timeFrame: up to 24 hours after the procedure
measure: Hematoma
timeFrame: up to 24 hours after the procedure
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
name: Ola T Abdel Dayem, MD
role: STUDY_CHAIR
affiliation: Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
name: Hazem Moawad, MD
role: STUDY_DIRECTOR
References: