Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Drug: intratracheal saline; Drug: intratracheal Dexmedetomidine; Drug: intratracheal Lidocaine

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61519
    • Minya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; At the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients.	Drug: intratracheal saline; At the end of the operation by 15min, 5ml of 0.9% normal saline was sprayed down the intratracheal tube of patients; Other Names: Group C
Active Comparator: 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	Drug: 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; Other Names: Group D
Active Comparator: Lidocaine; At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.	Drug: intratracheal Lidocaine; At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.; Other Names: Group L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough reflex.	To evaluate efficacy and safety of both dexmedetomidine and lidocaine on Cough: from time of awareness to 5 minute after extubation 0= no cough; minimal Cough (single); moderate cough<= 5S; severe cough >=5S (bucking)	from time of awareness to 5 minute after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial blood pressure	Perioperative mean arterial blood pressure values were recorded	before anesthesia up to 30 minute after extubation
heart rate	Perioperative heart rate values were recorded	before anesthesia up to 30 minute after extubation

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Director: Sohair A Magala, Lecturer, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: March 12, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: lidocaine; dexmedetomidine; intratracheal; eye-surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: 22-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No