Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patient.

N/AActive Not RecruitingNCT07832214

Sohag University120 enrolled

Overview

Study Hypothesis: The combination of dexmedetomidine and lidocaine administered as laryngopharyngeal topical spray provides superior suppression of extubation cough reflex compared to lidocaine alone or placebo, without compromising recovery or increasing adverse events

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

120

Conditions

Cough Suppression Thyroidectomy

Interventions

· Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volumeDRUG

* Dex-Lido solution: Dexmedetomidine 100 μg/mL (concentration) was diluted with 2% lidocaine to achieve final concentration of dexmedetomidine 1 μg/kg in 5 mL total volume * Lido solution: 2% lidocaine, 5 mL * Control solution: 0.9% normal saline, 5 mL All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray.

· Lido solution: 2% lidocaine, 5 mLDRUG

· Lido solution: 2% lidocaine, 5 mL All solutions were prepared under aseptic conditions immediately before use and loaded into identical 5 mL syringes attached to a mucosal atomization device (MADgic™, Teleflex Medical) capable of delivering fine-particle spray.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged 18-65 years * American Society of Anesthesiologists (ASA) physical status I-II * Scheduled for elective thyroidectomy under general anesthesia with endotracheal intubation * Provided written informed consent Exclusion Criteria: * Known allergy or contraindication to dexmedetomidine, lidocaine, or study medications * Pre-existing cough or respiratory tract infection within 2 weeks * History of chronic cough or reactive airway disease (asthma, COPD) * Significant cardiovascular disease (arrhythmias, uncontrolled hypertension, heart failure) * Hepatic or renal dysfunction (liver enzymes \>2× upper normal limit, creatinine \>1.5 mg/dL) * Pregnancy or breastfeeding * Anticipated difficult airway (Mallampati class III-IV, limited neck extension) * Preoperative use of antitussive medications or opioids * Body mass index \>35 kg/m² * Emergency surgery * Participation in another interventional trial within 30 days

Locations (1)

Faculty of Medicine, Sohag University

Sohag, Egypt

Outcomes

Primary Outcomes

Incidence of cough reflex during extubation

any visible or audible cough occurring from the time of endotracheal tube cuff deflation until 2 minutes following complete tube removal.

Time frame: 2 minutes following complete tube extubation

Secondary Outcomes

Cough Severity

Graded on a 4-point scale\]: * Grade 0: No cough * Grade 1: Single cough (mild) * Grade 2: Multiple coughs lasting \<5 seconds (moderate) * Grade 3: Sustained coughing \>5 seconds or severe paroxysms (severe)

Time frame: 10 minutes post extubations

Postoperative Sore Throat

using a 0-10 numerical rating scale (0 = no sore throat, 10 = worst imaginable sore throat) * Incidence of moderate-to-severe sore throat (score ≥4

Time frame: at 1, 6, 24, and 48 hours postoperatively

Data from ClinicalTrials.gov

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