Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Drug: intratracheal saline; Drug: intratracheal Lidocaine; Drug: intratracheal Dexmedetomidine

• Registration Number: NCT05291221
• Lead Sponsor: Minia University

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

Study Timeline

• Study Start: 2021-02-22
• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-03-12
• Study First Posted: 2022-03-22
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-29
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	intratracheal saline	At the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients.
Lidocaine	intratracheal Lidocaine	At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.
Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
Cough reflex.	from time of awareness to 5 minute after extubation	To evaluate efficacy and safety of both dexmedetomidine and lidocaine on Cough: from time of awareness to 5 minute after extubation 0= no cough; 1. minimal Cough (single); 2. moderate cough\<= 5S; 3. severe cough \>=5S (bucking)

Secondary Outcome Measures

Name	Time	Method
mean arterial blood pressure	before anesthesia up to 30 minute after extubation	Perioperative mean arterial blood pressure values were recorded
heart rate	before anesthesia up to 30 minute after extubation	Perioperative heart rate values were recorded

Trial Locations

Locations (1)

Minya University; 🇪🇬 Minya, Egypt