Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

NCT05291221 | Completed

• 1 other identifier: 22-2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

intratracheal; dexmedetomidine; eye-surgery; lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 1. minimal Cough (single) 2. moderate cough\<= 5S 3. severe cough \>=5S (bucking)

  from time of awareness to 5 minute after extubation

Secondary Outcomes (2)

• mean arterial blood pressure

  before anesthesia up to 30 minute after extubation

• heart rate

  before anesthesia up to 30 minute after extubation

Study Arms (3)

control

PLACEBO COMPARATOR

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

Dexmedetomidine

ACTIVE COMPARATOR

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

Lidocaine

ACTIVE COMPARATOR

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

Drug: intratracheal Lidocaine

Interventions

intratracheal saline DRUG

At the end of the operation by 15min, 5ml of 0.9% normal saline was sprayed down the intratracheal tube of patients

Also known as: Group C

control

intratracheal Dexmedetomidine DRUG

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

Also known as: Group D

Dexmedetomidine

intratracheal Lidocaine DRUG

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

Also known as: Group L

Lidocaine

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult patients aged from 18 to 60 years old
• ASA I or II class
• Undergo elective intraocular surgery
• Under general anesthesia.

You may not qualify if:

• Renal impairment
• Cardiorespiratory abnormalities
• Bronchial asthma COPD
• Restrictive lung diseases
• Liver failure
• Allergy to drugs will be used
• Patient refuse
• Pregnancy-lactation
• Significant obesity

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minya University

Minya, 61519, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sohair A Magala, Lecturer

  Lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor in of Anesthesia and Intensive Care units in Minia University hospital

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 22, 2022
• Study Start: February 22, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 30, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

EG (1)