Clinical trial NCT05291221: Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery
Official title: The Efficacy and Safety of Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Eye-surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: intratracheal
dexmedetomidine
eye-surgery
lidocaine
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The patients were randomly allocated into three groups each containing (40) patient. Group D received (0.5 μg/kg) of dexmedetomidine diluted and completed to 5 ml saline, Group L received (5ml) 2% of lidocaine and Group C received 5ml saline. The drugs were sprayed down the intratracheal tube of patients.

The following variables: Hemodynamic parameters HR, MAP, and SaO2 values in different times, preoperative IOP, cough, steward recovery score (SRS), detection of awareness and extubation time, the incidence of complications due to increasing IOP and surgeon satisfaction

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

Primary outcomes:
measure: Cough reflex.
timeFrame: from time of awareness to 5 minute after extubation
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: before anesthesia up to 30 minute after extubation
measure: heart rate
timeFrame: before anesthesia up to 30 minute after extubation
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya University
Study officials:
affiliation: Lecturer
name: Sohair A Magala, Lecturer
role: STUDY_DIRECTOR
References: