Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation
- Conditions
- Patient With Nasolacrimal Duct ObstructionExternal Dacryocystorhinostomy Operation
- Interventions
- Procedure: Mechanical ventilationOther: Head-up tilt
- Registration Number
- NCT05241054
- Lead Sponsor
- Mansoura University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
- American Society of Anesthesiologists physical status I and II
- patients who are scheduled for external Dacryocystorhinostomy operation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bupivacaine Mechanical ventilation Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Bupivacaine Head-up tilt Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Bupivacaine Paracetamol Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Nitroglycerine Mechanical ventilation Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Nitroglycerine Head-up tilt Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Bupivacaine Lactated Ringers Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Bupivacaine Fentanyl Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Bupivacaine Bupivacaine Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Bupivacaine Propofol Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Bupivacaine Atracurium Besylate Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Bupivacaine Sevoflurane Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Nitroglycerine Nitroglycerine Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Nitroglycerine Propofol Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Nitroglycerine Fentanyl Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Nitroglycerine Atracurium Besylate Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Nitroglycerine Sevoflurane Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Nitroglycerine Lactated Ringers Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg. Nitroglycerine Paracetamol Patients will receive an infusion of Nitroglycerine (TNG) (0.2-1μg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65 mmHg.
- Primary Outcome Measures
Name Time Method Average category scale (ACS) after 10 min of maintaining mean arterial blood pressure (MAP) at the desired range (55-65 mmHg) Assessment of intraoperative blood loss and quality of surgical field by Average category scale (ACS) for assessment of intraoperative surgical field (0-5): 0 - No bleeding 1 - Slight bleeding - no suctioning of blood required 2 - Slight bleeding 3- slight bleeding required suctioning 4- moderate bleeding 5- sever bleeding
- Secondary Outcome Measures
Name Time Method Mean arterial blood pressure procedure (basal reading and every 5 minutes till the end of anesthesia ) Mean arterial blood pressure values will be recorded
Postoperative visual analogue score (VAS) up to 24 hours after the procedure Pain levels will be assessed post operatively using visual analogue score (vas) at 0 min , 6 hour, 12hour , 24hours postoperatively .
Heart Rate (HR) procedure (basal reading and every 5 minutes till the end of anesthesia) Heart Rat values will be recorded
Postoperative analgesics intake up to 24 hours after the procedure Total dose of ketorolac requirements will be recorded
Surgeon satisfaction at the end of the procedure Surgeon satisfaction will be recorded based on a 4 points scale (1=bad, 2=moderate, 3=good, 4=excellent).
Hematoma up to 24 hours after the procedure The patients will be evaluated postoperatively to identify the occurrence of hematoma (blood collection, swelling, bruises) at the site of injection of bupivacaine.
Nausea up to 24 hours after the procedure Postoperative Nausea will be assessed on a scale of 0 to 3 \[0; no nausea, 1, mild nausea, 2; moderate nausea, 3; severa nausea\]
Vomiting up to 24 hours after the procedure Postoperative Vomiting will be assessed on a scale of 0 to 3 \[0; no vomiting, 1, mild vomiting, 2; moderate vomiting, 3; severe vomiting\]
Trial Locations
- Locations (1)
Mansoura University
🇪🇬Mansoura, DK, Egypt