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

NCT05241054 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-02-15

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ola T Abdel Dayem, MD · Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

  • Hazem Moawad, MD · Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-09-30
Completion
2023-03-31

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05241054 on ClinicalTrials.gov