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

NCT05241054 | Unknown DMC

• 1 other identifier: MD / 21.09.536
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Patient With Nasolacrimal Duct Obstruction; External Dacryocystorhinostomy Operation

Outcome Measures

Primary Outcomes (1)

• 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

  after 10 min of maintaining mean arterial blood pressure (MAP) at the desired range (55-65 mmHg)

Secondary Outcomes (8)

• Mean arterial blood pressure

  procedure (basal reading and every 5 minutes till the end of anesthesia )

• Heart Rate (HR)

  procedure (basal reading and every 5 minutes till the end of anesthesia)

• Postoperative visual analogue score (VAS)

  up to 24 hours after the procedure

• Postoperative analgesics intake

  up to 24 hours after the procedure

• Surgeon satisfaction

  at the end of the procedure

Study Arms (2)

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.

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.

Drug: Nitroglycerine; Drug: Propofol; Drug: Fentanyl; Drug: Atracurium Besylate; Procedure: Mechanical ventilation; Drug: Sevoflurane; Drug: Lactated Ringers; Other: Head-up tilt; Drug: Paracetamol

Interventions

Bupivacaine DRUG

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.

Bupivacaine

Nitroglycerine DRUG

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.

Nitroglycerine

Propofol DRUG

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

Bupivacaine; Nitroglycerine

Fentanyl DRUG

fentanyl 1 microgram.kg

Bupivacaine; Nitroglycerine

Atracurium Besylate DRUG

Atracurium besylate 0.5mg.kg to facilitate intubation followed will top up dose of atracurium(0.1mg/kg).

Bupivacaine; Nitroglycerine

Mechanical ventilation PROCEDURE

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

Bupivacaine; Nitroglycerine

Sevoflurane DRUG

Anesthesia will then be maintained using sevoflurane 2%, and 60% air in oxygen mixture and top up dose of

Bupivacaine; Nitroglycerine

Lactated Ringers DRUG

Intravenous infusion of Lactated Ringers will be given per body weight and according to intraoperative loss

Bupivacaine; Nitroglycerine

Head-up tilt OTHER

The patient is placed on the operating table with a head-up tilt to reduce venous congestion at the operative site

Bupivacaine; Nitroglycerine

Paracetamol DRUG

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

Bupivacaine; Nitroglycerine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Nitroglycerin; Propofol; Fentanyl; Atracurium; Respiration, Artificial; Sevoflurane; Ringer's Lactate; Acetaminophen

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Nitro Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Acetanilides

Study Officials

• Ola T Abdel Dayem, MD

  Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

  STUDY CHAIR

• Hazem Moawad, MD

  Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Ola T Abdel Dayem, MD

CONTACT

00201202811110; olataha2007@yahoo.com

Hazem Moawad, MD

CONTACT

00201121516041; hazemmoawad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind study (patient and data collector)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 15, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After six months after completing the study.

Locations

EG (1)