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Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intratracheal saline
intratracheal Dexmedetomidine
intratracheal Lidocaine
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring intratracheal, dexmedetomidine, eye-surgery, lidocaine

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minya University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control

Dexmedetomidine

Lidocaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

mean arterial blood pressure
Perioperative mean arterial blood pressure values were recorded
heart rate
Perioperative heart rate values were recorded

Full Information

First Posted
February 19, 2022
Last Updated
July 29, 2023
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05291221
Brief Title
Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery
Official Title
The Efficacy and Safety of Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Eye-surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
intratracheal, dexmedetomidine, eye-surgery, lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
At the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients.
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.
Intervention Type
Drug
Intervention Name(s)
intratracheal saline
Other Intervention Name(s)
Group C
Intervention Description
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
Intervention Name(s)
intratracheal Dexmedetomidine
Other Intervention Name(s)
Group D
Intervention Description
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
Intervention Name(s)
intratracheal Lidocaine
Other Intervention Name(s)
Group L
Intervention Description
At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.
Primary Outcome Measure Information:
Title
Cough reflex.
Description
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)
Time Frame
from time of awareness to 5 minute after extubation
Secondary Outcome Measure Information:
Title
mean arterial blood pressure
Description
Perioperative mean arterial blood pressure values were recorded
Time Frame
before anesthesia up to 30 minute after extubation
Title
heart rate
Description
Perioperative heart rate values were recorded
Time Frame
before anesthesia up to 30 minute after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohair A Magala, Lecturer
Organizational Affiliation
Lecturer
Official's Role
Study Director
Facility Information:
Facility Name
Minya University
City
Minya
ZIP/Postal Code
61519
Country
Egypt

12. IPD Sharing Statement

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Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

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