Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291221
• Other study ID #: 22-2021
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: July 2023
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 30, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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
• 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
• intratracheal Lidocaine
At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.

Locations

Country	Name	City	State
Egypt	Minya University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mean arterial blood pressure	Perioperative mean arterial blood pressure values were recorded	before anesthesia up to 30 minute after extubation
Secondary	heart rate	Perioperative heart rate values were recorded	before anesthesia up to 30 minute after extubation