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

NCT ID: NCT05657028

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-09-01

Brief Summary

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.

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.

Conditions

Anesthesia; Airway Complication of Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group D (Dexmedetomidine)

In the Dexmedetomidine group, patients will be given IV bolus infusion of dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

-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.

Group L (Lidocaine)

In the Lidocaine group, the patients will be given an IV bolus infusion of lidocaine

Group Type: EXPERIMENTAL

Lidocaine IV

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ainshams University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ola N Hussain Zaher, MSC

Role: CONTACT

ano_triple@hotmail.com

+201003067762

Facility Contacts

Ola N Hussain Zaher, MSc

Role: primary

ano_triple@hotmail.com

+201003067762

References

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.

Reference Type: RESULT

PMID: 31054568 (View on PubMed)

Other Identifiers

attenuating airway reflexes

Identifier Type: -

Identifier Source: org_study_id