Dexmedetomidine Versus Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients

Intravenous Dexmedetomidine Versus Intravenous Lidocaine in Attenuating Airway Reflexes During Recovery of Thyroidectomy Patients

It is widely believed that most of the patients experience a cough upon emergence from general anesthesia, due to many causes including the presence of an endotracheal tube, uncleared secretions and anesthetic gas. Cough during tracheal extubation may lead to several complications, such as hypertension, tachycardia and postoperative bleeding.

In this study the investigators are going to compare the effectiveness of intravenous Dexmedetomidine and intravenous lidocaine in attenuating the air way reflexes and coughing during recovery of thyroidectomy patients.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Airway Complication of Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Lidocaine IV

Detailed Description

Intubation and extubation process are associated with cardiovascular and various airway responses leading to tachycardia, hypertension, arrhythmia, myocardial ischemia, cough induction, bronchospasm, increased bleeding, increased intracranial and intraocular pressure. Causes possibly include the presence of an endotracheal tube, uncleared secretions, and anesthetic gas.

Furthermore, postoperative bleeding in thyroid surgery is still significant and is often associated with severe complications including cervical hematoma, reoperation and cardiac arrest.

Extubation under deep anesthesia decreases cardiovascular stimulation and reduces the incidence of coughing and straining on the tube. Intratracheal local anesthetic instillation, I.V lidocaine, short acting opioids such as fentanyl and remifentanil, esmolol, labetalol, diltiazem and verapamil have been used to attenuate these hemodynamic and respiratory responses during extubation in the past but with certain limitations.

Also "no stimulation" extubation technique avoids extubation under light anesthesia and ensures extubation only when consciousness is returned. It requires absolutely no stimulation during emergence and performing extubation only when the patient wakes up spontaneously and opens his eyes.

Recently dexmedetomidine, a potent α2-adrenoreceptor agonist has been used to facilitate extubation in surgical intensive care unit, but its role in the attenuation of hemodynamic and airway reflexes during extubation in general anesthesia is still under study.

In this study the investigators are going to compare the effects of intravenous lidocaine and dexmedetomidine in inhibiting cough reflex during the recovery period after thyroid surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ola N Hussain Zaher, MSc; Phone Number: +201003067762; Email: ano_triple@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Ainshams university hospitals
    • Contact: Ola N Hussain Zaher, MSc; Phone Number: +201003067762; Email: ano_triple@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for elective thyroidectomy surgery.
• Age: patients between 18-and 65-years old from both sexes.
• Classified as either American Society of Anesthesiologists (ASA) class I or II.

Exclusion Criteria:

• Refusal of procedure or participation in the study.
• Patients suffering from asthma, chronic cough, preoperative upper respiratory infection symptoms.
• Current smoker.
• Medication involving angiotensin-converting-enzyme inhibitors (ACE-I).
• Classified as either American Society of Anesthesiologists (ASA) class III or IV.
• Sinus Bradycardia (<60/min) or history of any type of heart block or Beta-Blockers medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D (Dexmedetomidine); In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine	Drug: Dexmedetomidine; -In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine 0.5 μg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4 μg/kg/hour until 30 min before the end of surgery.
Experimental: Group L (Lidocaine); In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine	Drug: Lidocaine IV; In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine (2%)1.5mg/kg over 10 min before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg /hour until 30 min before the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare effectiveness of Dexmedetomidine and intravenous lidocaine in attenuating cough reflex during the tracheal extubation period after thyroid surgery	the investigators use the following cough score where 0 = no cough, 1 = minimal (single) cough, 2 = moderate (≤5 seconds) cough and 3 = severe (>5 seconds) cough to reflect the degree of attenuation of air way reflexes for each group	5 minutes from extubation

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• Hu S, Li Y, Wang S, Xu S, Ju X, Ma L. Effects of intravenous infusion of lidocaine and dexmedetomidine on inhibiting cough during the tracheal extubation period after thyroid surgery. BMC Anesthesiol. 2019 May 4;19(1):66. doi: 10.1186/s12871-019-0739-1.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: December 10, 2022
• First Posted (Estimate): December 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: attenuating airway reflexes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No