Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation
NCT05241054 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2022-02-15
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
Conditions
- Patient With Nasolacrimal Duct Obstruction
- External Dacryocystorhinostomy Operation
Interventions
- DRUG
-
Bupivacaine
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.
- DRUG
-
Nitroglycerine
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.
- DRUG
-
Propofol
General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg
- DRUG
-
fentanyl 1 microgram.kg
- DRUG
-
Atracurium Besylate
Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).
- PROCEDURE
-
Mechanical ventilation
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
- DRUG
-
Sevoflurane
Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of
- DRUG
-
Lactated Ringers
Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss
- OTHER
-
Head-up tilt
The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site
- DRUG
-
paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
Sponsors & Collaborators
-
Mansoura University
lead OTHER
Principal Investigators
-
Ola T Abdel Dayem, MD · Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
-
Hazem Moawad, MD · Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2022-09-30
- Completion
- 2023-03-31
Countries
- Egypt
Study Locations
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