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Clinical trial

The Efficacy and Safety of Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Eye-surgery.

ID
Name
22-2021
Description
Cough during emergence from general anesthesia is considered a critical event as it may lead to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in patients who are at risk of complications related to increases in intracranial or intraocular pressure. Lidocaine administration has been widely used for reducing cough during extubation due to its simplicity and lack of serious adverse effects; There are two major routes for lidocaine administration systemic intravenous injection and local direct application on the laryngeal inlets such as spraying lidocaine on the supraglottic and subglottic regions or applying lidocaine jelly or sprayed. Dexmedetomidine is a potent alpha 2 selective adrenoceptor agonist and the most characteristic features include sympatholytic sedation analgesia and lack of respiratory depression. The aim of this study is to compare the effect of intratracheal dexmedetomidine and lidocaine on cough reflex in cataract surgery.
Trial arms
Trial start
2021-02-22
Estimated PCD
2022-07-01
Trial end
2022-07-30
Status
Completed
Treatment
intratracheal saline
At the end of the operation by 15min, 5ml of 0.9% normal saline was sprayed down the intratracheal tube of patients
Arms:
control
Other names:
Group C
intratracheal Dexmedetomidine
At the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients
Arms:
Dexmedetomidine
Other names:
Group D
intratracheal Lidocaine
At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.
Arms:
Lidocaine
Other names:
Group L
Size
120
Primary endpoint
Cough reflex.
from time of awareness to 5 minute after extubation
Eligibility criteria
Inclusion Criteria: * Adult patients aged from 18 to 60 years old * ASA I or II class * Undergo elective intraocular surgery * Under general anesthesia. Exclusion Criteria: * Renal impairment * Cardiorespiratory abnormalities * Bronchial asthma COPD * Restrictive lung diseases * Liver failure * Allergy to drugs will be used * Patient refuse * Pregnancy-lactation * Significant obesity
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2023-08-01

1 organization

3 products

1 indication

Organization
Minia University
Product
Intratracheal Saline
Indication
Postoperative Complications
Product
Dexmedetomidine
Product
Lidocaine