Patient With Nasolacrimal Duct ObstructionNCT05241054
Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation
A study testing Bupivacaine, Nitroglycerine and Propofol in people with Patient With Nasolacrimal Duct Obstruction and External Dacryocystorhinostomy Operation, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patient With Nasolacrimal Duct Obstruction, External Dacryocystorhinostomy Operation
- What is being tested?
- Bupivacaine, Nitroglycerine and Propofol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I and II
- patients who are scheduled for external Dacryocystorhinostomy operation
Who cannot join
- 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.
Show all 10Show fewer
- Patients with any type of arrhythmias.
- Hematological diseases.
- Bleeding abnormality
- Coagulation abnormality
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University
Al Mansurah, DK, 050
Ola T Abdel Dayem, MD, 00201202811110, olataha2007@yahoo.com
Hazem Moawad, MD, 00201121516041, hazemmoawad@yahoo.com
About this study
Official title: Comparison of Local Anesthesia and Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation Under General Anesthesia
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
Read the 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
- Being tested
- Bupivacaine, Nitroglycerine, Propofol, Fentanyl, Atracurium Besylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
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.
NitroglycerineDrug
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.
PropofolDrug
General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg
FentanylDrug
fentanyl 1 microgram.kg
Atracurium BesylateDrug
Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).
Mechanical ventilationProcedure or surgery
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
SevofluraneDrug
Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of
Lactated RingersDrug
Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss
Head-up tiltOther
The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site
ParacetamolDrug
paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. Receives: Drug: Bupivacaine; Drug: Propofol; Drug: Fentanyl; Drug: Atracurium Besylate; Procedure: Mechanical ventilation; Drug: Sevoflurane; Drug: Lactated Ringers; Other: Head-up tilt; Drug: Paracetamol |
| Nitroglycerine | Active comparator | 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. Receives: Drug: Nitroglycerine; Drug: Propofol; Drug: Fentanyl; Drug: Atracurium Besylate; Procedure: Mechanical ventilation; Drug: Sevoflurane; Drug: Lactated Ringers; Other: Head-up tilt; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 10 min of maintaining mean arterial blood pressure (MAP) at the desired range (55-65 mmHg)
Secondary outcomes (8)
Mean arterial blood pressure
Mean arterial blood pressure values will be recorded
Measured: procedure (basal reading and every 5 minutes till the end of anesthesia )
Heart Rate (HR)
Heart Rat values will be recorded
Measured: 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 .
Measured: up to 24 hours after the procedure
Postoperative analgesics intake
Total dose of ketorolac requirements will be recorded
Measured: 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).
Measured: 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]
Measured: 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]
Measured: 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.
Measured: up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ola T Abdel Dayem, MD, Study chair, Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, EgyptHazem Moawad, MD, Study director, Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241054
- Sponsor's protocol ID
- MD / 21.09.536
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual data sharing strategy. The data that support the findings of this study will be available on request from a principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Local Anesthesia and Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05241054
- Acronym / sponsor ID
- MD / 21.09.536
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacaine, Drug: Propofol, Drug: Fentanyl, Drug: Atracurium Besylate, Procedure: Mechanical ventilation, Drug: Sevoflurane, Drug: Lactated Ringers, Other: Head-up tilt, Drug: ParacetamolPatients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine. |
| Nitroglycerine | Active comparator | Drug: Nitroglycerine, Drug: Propofol, Drug: Fentanyl, Drug: Atracurium Besylate, Procedure: Mechanical ventilation, Drug: Sevoflurane, Drug: Lactated Ringers, Other: Head-up tilt, Drug: ParacetamolPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I and II
- patients who are scheduled for external Dacryocystorhinostomy operation
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineWith 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 | Bupivacaine |
| NitroglycerineThis 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 | Nitroglycerine |
| PropofolGeneral anesthesia will be induced using IV propofol at dose of 1-2 mg.kg | Drug | Bupivacaine, Nitroglycerine |
| Fentanylfentanyl 1 microgram.kg | Drug | Bupivacaine, Nitroglycerine |
| Atracurium BesylateAtracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg). | Drug | Bupivacaine, Nitroglycerine |
| Mechanical ventilationPatient 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 | Procedure or surgery | Bupivacaine, Nitroglycerine |
| SevofluraneAnesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of | Drug | Bupivacaine, Nitroglycerine |
| Lactated RingersIntravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss | Drug | Bupivacaine, Nitroglycerine |
| Head-up tiltThe patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site | Other | Bupivacaine, Nitroglycerine |
| Paracetamolparacetamol infusion (15 mg/kg) will be given by IV infusion in both groups | Drug | Bupivacaine, Nitroglycerine |
Primary outcome
Average category scale (ACS)
Time frame: 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
8 secondary outcomes
Mean arterial blood pressure
Time frame: procedure (basal reading and every 5 minutes till the end of anesthesia )
Heart Rate (HR)
Time frame: procedure (basal reading and every 5 minutes till the end of anesthesia)
Postoperative visual analogue score (VAS)
Time frame: up to 24 hours after the procedure
Postoperative analgesics intake
Time frame: up to 24 hours after the procedure
Surgeon satisfaction
Time frame: at the end of the procedure
Nausea
Time frame: up to 24 hours after the procedure
Vomiting
Time frame: up to 24 hours after the procedure
Hematoma
Time frame: up to 24 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Yes. The individual data sharing strategy. The data that support the findings of this study will be available on request from a principal investigator
Related trials for Patient With Nasolacrimal Duct Obstruction
RecruitingPhase 3
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
Nasolacrimal Duct Obstruction, Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola T Abdel Dayem, MD study chair
Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Hazem Moawad, MD study director
Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Nitroglycerine and Propofol in people with Patient With Nasolacrimal Duct Obstruction and External Dacryocystorhinostomy Operation, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ola T Abdel Dayem, MD (00201202811110, olataha2007@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average category scale (ACS) (time frame: after 10 min of maintaining mean arterial blood pressure (MAP) at the desired range (55-65 mmHg)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.