Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05241054

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Patient With Nasolacrimal Duct Obstruction External Dacryocystorhinostomy Operation	Drug: Bupivacaine Drug: Nitroglycerine Drug: Propofol Drug: Fentanyl Drug: Atracurium Besylate Procedure: Mechanical ventilation Drug: Sevoflurane Drug: Lactated Ringers Other: Head-up tilt Drug: Paracetamol	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double-blind study (patient and data collector)

Primary Purpose:

Prevention

Official Title:

Comparison of Local Anesthesia and Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation Under General Anesthesia

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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: Propofol General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg Drug: Fentanyl 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 paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
Active Comparator: 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.	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 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 paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups

Arm

Intervention/Treatment

Active Comparator: 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.

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: Propofol

General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg

Drug: Fentanyl

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

paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups

Active Comparator: 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.

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

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

paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups

Outcome Measures

Primary Outcome Measures

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

Mean arterial blood pressure [procedure (basal reading and every 5 minutes till the end of anesthesia )]
Mean arterial blood pressure values will be recorded
Heart Rate (HR) [procedure (basal reading and every 5 minutes till the end of anesthesia)]
Heart Rat 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 .
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).
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists physical status I and II
patients who are scheduled for external Dacryocystorhinostomy operation

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura	DK	Egypt	050

Sponsors and Collaborators

Mansoura University

Investigators

Study Chair: Ola T Abdel Dayem, MD, Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Study Director: Hazem Moawad, MD, Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt