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Completed

NCT Number: NCT05291221

Intratracheal Dexmedetomidine Versus Lidocaine in 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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minya University

Minya, 61519, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Group C

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

Other names: Group D

intratracheal Lidocaine

Drug

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

Other names: Group L

Primary outcomes

  1. Cough reflex.

    Time frame: 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

    • minimal Cough (single)
    • moderate cough<= 5S
    • severe cough >=5S (bucking)

Secondary outcomes

  1. mean arterial blood pressure

    Time frame: before anesthesia up to 30 minute after extubation

    Perioperative mean arterial blood pressure values were recorded

  2. heart rate

    Time frame: before anesthesia up to 30 minute after extubation

    Perioperative heart rate values were recorded

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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