Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

NCT ID: NCT05291221

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2022-07-30

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

Conditions

Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control

At the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients.

Group Type: PLACEBO_COMPARATOR

intratracheal saline

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

intratracheal Dexmedetomidine

Intervention Type: 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

Lidocaine

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

Group Type: ACTIVE_COMPARATOR

intratracheal Lidocaine

Intervention Type: DRUG

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

Interventions

intratracheal saline

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

Intervention Type: 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

Intervention Type: DRUG

intratracheal Lidocaine

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

Intervention Type: DRUG

Other Intervention Names

Group C; Group D; Group L

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

haidy salah mansour

Assistant professor in of Anesthesia and Intensive Care units in Minia University hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sohair A Magala, Lecturer

Role: STUDY_DIRECTOR

Lecturer

Locations

Minya University

Minya, , Egypt

Countries

Egypt

Other Identifiers

22-2021

Identifier Type: -

Identifier Source: org_study_id