An interventional study of Bupivacaine and Nitroglycerine in Patient With Nasolacrimal Duct Obstruction and External Dacryocystorhinostomy Operation, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Mansoura University · Not applicable, Interventional, and Prevention
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
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
Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine.
Drug: Bupivacaine · Drug: Propofol · Drug: Fentanyl · Drug: Atracurium Besylate · Procedure: Mechanical ventilation · Drug: Sevoflurane · Drug: Lactated Ringers · Other: Head-up tilt · Drug: 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.
Drug: Nitroglycerine · Drug: Propofol · Drug: Fentanyl · Drug: Atracurium Besylate · Procedure: Mechanical ventilation · Drug: Sevoflurane · Drug: Lactated Ringers · Other: Head-up tilt · Drug: Paracetamol
With patient in supine position, the patient will be placed on the operating table with a head-up tilt to reduce venous congestion at the operative site. Skin will be disinfected, the patient will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine.
This group includes 32 patients (anticipated), infusion of Nitroglycerine (TNG) (0.2-1µg/kg/min) will be started and adjusted to maintain mean arterial blood pressure between 55-65mmHg.
General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg
fentanyl 1 microgram.kg
Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).
Patient will then be mechanically ventilated using a volume control mode with tidal volume 6-8ml/kg, respiratory rate 10-14 breath/min and I.E ratio1:2 to maintain end tidal CO2 around 35 mmHg
Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of
Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss
The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site
paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
Average category scale (ACS)
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
Time frame: after 10 min of maintaining mean arterial blood pressure (MAP) at the desired range (55-65 mmHg)
Mean arterial blood pressure
Mean arterial blood pressure values will be recorded
Time frame: procedure (basal reading and every 5 minutes till the end of anesthesia )
Heart Rate (HR)
Heart Rat values will be recorded
Time frame: procedure (basal reading and every 5 minutes till the end of anesthesia)
Postoperative visual analogue score (VAS)
Pain levels will be assessed post operatively using visual analogue score (vas) at 0 min , 6 hour, 12hour , 24hours postoperatively .
Time frame: up to 24 hours after the procedure
Postoperative analgesics intake
Total dose of ketorolac requirements will be recorded
Time frame: up to 24 hours after the procedure
Surgeon satisfaction
Surgeon satisfaction will be recorded based on a 4 points scale (1=bad, 2=moderate, 3=good, 4=excellent).
Time frame: at the end of the procedure
Nausea
Postoperative Nausea will be assessed on a scale of 0 to 3 \[0; no nausea, 1, mild nausea, 2; moderate nausea, 3; severa nausea\]
Time frame: up to 24 hours after the procedure
Vomiting
Postoperative Vomiting will be assessed on a scale of 0 to 3 \[0; no vomiting, 1, mild vomiting, 2; moderate vomiting, 3; severe vomiting\]
Time frame: up to 24 hours after the procedure
Hematoma
The patients will be evaluated postoperatively to identify the occurrence of hematoma (blood collection, swelling, bruises) at the site of injection of bupivacaine.
Time frame: up to 24 hours after the procedure
Plan to share: Yes — The individual data sharing strategy. The data that support the findings of this study will be available on request from a principal investigator
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After six months after completing the study.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bupivacaine · Nitroglycerin