Laryngospasm, Post-anesthesia cough, Oxygen desaturation, Post-extubation airway complications. Cough
Conditions
Interventions
Intervention 1: Intervention group: Intravenous lidocaine 1.5 mg/kg of 2 percent solution (20 mg per mL). Slow injection over 60 seconds, administered 90 seconds before endotracheal intubation. Interv
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adult patients aged 18 to 65 years Candidates for elective orthopedic surgery under general anesthesia with endotracheal intubation American Society of Anesthesiologists (ASA) physical status I or II Written informed consent obtained
Exclusion criteria
Exclusion criteria: Known hypersensitivity or allergy to lidocaine or amide-type local anesthetics History of asthma or chronic obstructive pulmonary disease (COPD) Predicted difficult airway or need for awake intubation Upper respiratory tract infection within the past two weeks Pregnancy Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any of the following within 10 minutes after tracheal extubation: laryngospasm (partial or complete), severe cough (cough score 2 or higher on a 0-3 scale), or oxygen desaturation below 90% for more than 15 seconds. Timepoint: The primary outcome is measured within 10 minutes after tracheal extubation. Laryngospasm and cough are assessed continuously during this time period. Desaturation is monitored continuously by pulse oximetry. Method of measurement: Laryngospasm: Clinical observation by a trained assessor, recorded as partial (stridor with partial airflow) or complete (no airflow despite inspiratory effort)Severe cough: Four-point cough severity scale (0 = no cough, 1 = single cough, 2 = mild to moderate cough up to 5 times, 3 = severe cough more than 5 times or sustained coughing)Oxygen desaturation: Hospital pulse oximeter with finger probe, recording sustained desaturation below 90% for more than 15 seconds. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of laryngospasm (alone) within 10 minutes after tracheal extubation. Timepoint: Continuously during the 10 minutes after tracheal extubation. Method of measurement: Clinical observation by a trained assessor. Partial laryngospasm: presence of stridor with partial airflow. Complete laryngospasm: absence of airflow despite the patient's inspiratory effort.;Occurrence of severe cough (alone) within 10 minutes after tracheal extubation. Timepoint: Continuously during the 10 minutes after tracheal extubation. Method of measurement: Four-point cough severity scale (0 = no cough, 1 = single cough, 2 = mild to moderate cough up to 5 times, 3 = severe cough more than 5 times or sustained coughing). A trained assessor blinded to group allocation records the score.;Occurrence of oxygen desaturation below 90 percent alone within 10 minutes after tracheal extubation. Timepoint: Continuously during the 10 minutes after tracheal extubation by pulse oximeter. Method of measurement: Hospital pulse oximeter with finger probe. Desaturation is defined as oxygen saturation below 90 percent lasting for more than 15 seconds. A trained assessor blinded to group allocation records the event.;Severity of cough during endotracheal intubation based on a four-point scale. Timepoint: At the moment of passing the endotracheal tube through the vocal cords until cuff inflation (maximum 30 seconds). Method of measurement: Four-point cough severity scale (0 = no cough, 1 = single cough, 2 = mild to moderate cough up to 5 times, 3 = severe cough more than 5 times or sustained coughing). Recorded by the attending anesthesiologist (note: the anesthesiologist is aware of group allocation, which is a limitation of the study).;Severity of cough during tracheal extubation based on a four-point scale. Timepoint: At the moment of removing the endotracheal tube from the trachea until complete removal from the mouth (maximum 20 seconds). Method of measurement: Four-point cough severity scale (0 = no | — |
Countries
Iraq
Contacts
Public ContactElham Shahidi Delshad
Tehran University of Medical Sciences
Outcome results
None listed