Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation
NCT ID: NCT05241054
Last Updated: 2022-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
64 participants
INTERVENTIONAL
2022-03-31
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy
NCT05507476
Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery
NCT05361642
Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery
NCT05291221
Effect of Topically Administered Levobupivacaine- Fentanyl Versus Levobupivacaine- Dexamethasone Combination in the Control of Pain After Endoscopic Sinus Surgery
NCT05145543
The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine
NCT05828199
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Propofol
General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg
Fentanyl
fentanyl 1 microgram.kg
Atracurium Besylate
Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).
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
Sevoflurane
Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of
Lactated Ringers
Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss
Head-up tilt
The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site
Paracetamol
paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
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
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.
Propofol
General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg
Fentanyl
fentanyl 1 microgram.kg
Atracurium Besylate
Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).
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
Sevoflurane
Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of
Lactated Ringers
Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss
Head-up tilt
The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site
Paracetamol
paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Propofol
General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg
Fentanyl
fentanyl 1 microgram.kg
Atracurium Besylate
Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).
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
Sevoflurane
Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of
Lactated Ringers
Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss
Head-up tilt
The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site
Paracetamol
paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients who are scheduled for external Dacryocystorhinostomy operation
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mansoura University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ola T Abdel Dayem, MD
Role: STUDY_CHAIR
Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Hazem Moawad, MD
Role: STUDY_DIRECTOR
Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mansoura University
Al Mansurah, DK, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD / 21.09.536
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.