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

Primary Purpose

Patient With Nasolacrimal Duct Obstruction, External Dacryocystorhinostomy Operation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine
Nitroglycerine
Propofol
Fentanyl
Atracurium Besylate
Mechanical ventilation
Sevoflurane
Lactated Ringers
Head-up tilt
Paracetamol
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patient With Nasolacrimal Duct Obstruction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacaine

Nitroglycerine

Arm Description

Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean arterial blood pressure
Mean arterial blood pressure values will be recorded
Heart Rate (HR)
Heart Rat values will be recorded
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 .
Postoperative analgesics intake
Total dose of ketorolac requirements will be recorded
Surgeon satisfaction
Surgeon satisfaction will be recorded based on a 4 points scale (1=bad, 2=moderate, 3=good, 4=excellent).
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]
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]
Hematoma
The patients will be evaluated postoperatively to identify the occurrence of hematoma (blood collection, swelling, bruises) at the site of injection of bupivacaine.

Full Information

First Posted
January 24, 2022
Last Updated
February 6, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05241054
Brief Title
Effect of Local Anesthesia Versus Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation
Official Title
Comparison of Local Anesthesia and Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Nasolacrimal Duct Obstruction, External Dacryocystorhinostomy Operation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind study (patient and data collector)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Patients will receive local anesthesia by paranasal infiltration at the incision site with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine.
Arm Title
Nitroglycerine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitroglycerine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
General anesthesia will be induced using IV propofol at dose of 1-2 mg.kg
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
fentanyl 1 microgram.kg
Intervention Type
Drug
Intervention Name(s)
Atracurium Besylate
Intervention Description
Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).
Intervention Type
Procedure
Intervention Name(s)
Mechanical ventilation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of
Intervention Type
Drug
Intervention Name(s)
Lactated Ringers
Intervention Description
Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss
Intervention Type
Other
Intervention Name(s)
Head-up tilt
Intervention Description
The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
paracetamol infusion (15 mg/kg) will be given by IV infusion in both groups
Primary Outcome Measure Information:
Title
Average category scale (ACS)
Description
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)
Secondary Outcome Measure Information:
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure values will be recorded
Time Frame
procedure (basal reading and every 5 minutes till the end of anesthesia )
Title
Heart Rate (HR)
Description
Heart Rat values will be recorded
Time Frame
procedure (basal reading and every 5 minutes till the end of anesthesia)
Title
Postoperative visual analogue score (VAS)
Description
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
Title
Postoperative analgesics intake
Description
Total dose of ketorolac requirements will be recorded
Time Frame
up to 24 hours after the procedure
Title
Surgeon satisfaction
Description
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
Title
Nausea
Description
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
Title
Vomiting
Description
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
Title
Hematoma
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ola T Abdel Dayem, MD
Phone
00201202811110
Email
olataha2007@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hazem Moawad, MD
Phone
00201121516041
Email
hazemmoawad@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola T Abdel Dayem, MD
Organizational Affiliation
Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hazem Moawad, MD
Organizational Affiliation
Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola T Abdel Dayem, MD
Phone
00201202811110
Email
olataha2007@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hazem Moawad, MD
Phone
00201121516041
Email
hazemmoawad@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohamed M Tawfik, MD
First Name & Middle Initial & Last Name & Degree
Ola S Elnagar, M.Sec

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual data sharing strategy. The data that support the findings of this study will be available on request from a principal investigator
IPD Sharing Time Frame
After six months after completing the study.

Learn more about this trial

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

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