Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer

Study Overview
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Brief Summary
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Background: During emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax. Dexmedetomidine is a selective α2-adrenoreceptor agonist that has sedative, analgesic, and sympatholytic properties. It has been reported dexmedetomidine can attenuate coughing reflex and prevent emergence agitation without delaying recovery and respiratory depression from general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine compared with midazolam on cough suppression and recovery quality during emergence from general anesthesia after partial and total laryngectomy. Methods American Society of Anesthesiologists physical status I-II male adults undergoing elective laryngectomy under sevoflurane anesthesia were recruiting and randomly allocated to receive either dexmedetomidine(Group D, n = 60) infusion at 0.5 µg•kg-1 for 10 min before tracheotomy, then adjusted to 0.3µg•kg-1•h-1 or midazolam (Group M, n = 60) infusion at 0.05 mg•kg-1 ten minutes before tracheotomy, then adjusted to 0.02mg•kg-1•h-1. The primary outcome measure was the incidence and severity of cough. Hemodynamics, pain intensity [Visual Analogue Scale (VAS)] and Ramsay sedation scale (RSS) were also evaluated at awake, patients returning to ward from post anesthesia care unit (PACU),2h after surgery. postoperative sufentanil consumption, recovery time and the incidence of concerning adverse effects were recorded.

Official Title
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A Randomized Controlled Trial of the Effect of Dexmedetomidine Compared With Midazolam on Airway Reflex and Recovery Quality During Emergence From General Anesthesia After Partial and Total Laryngectomy

Conditions
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Laryngectomy; Status

Intervention / Treatment
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* Drug: Dexmedetomidine Injectable Product
* Drug: Midazolam injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject scheduled for partial or total laryngectomy. Exclusion Criteria: Subject has respiratory disease; Subject has pharyngeal paraganglioma; Subject has cardiac disease; Uncontrolled hypertension; Subject has been taking β-adrenoreceptor blockers; Long-term abuse of alcohol (>6 months),opioids, or sedative-hypnotic drugs; Allergic to dexmedetomidine or midazolam; Subject has neuropsychiatric diseases; Operation time shorter than 1 h or longer than 4 h.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>patients receive dexmedetomidine infusion | Drug: Dexmedetomidine Injectable Product<br>* dexmedetomidine infusion at 0.5 µg•kg-1 for 10 min before tracheotomy then adjusted to 0.3µg•kg-1•h-1<br>|
| Experimental: midazolam<br>patients receive midazolam infusion | Drug: Midazolam injection<br>* midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of cough | Coughing severity was classified using the 3-point scale.:1=mild (single) cough, 2=moderate (≤5 s) cough, and 3=severe (>5 s) cough. | Time0:2hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HR | Heart rate | Time0: 0 minute after arriving the operation room | 
| SBP | Systolic blood pressure | Time0: 0 minute after arriving the operation room | 
| DBP | Diastolic blood pressure | Time0: 0 minute after arriving the operation room | 
| SpO2 | Oxygen saturation using pulse oximetry | Time0: 0 minute after arriving the operation room | 
| HR | Heart rate | Time1:0 minute after drug administration | 
| SBP | Systolic blood pressure | Time1:0 minute after drug administration | 
| DBP | Diastolic blood pressure | Time1:0 minute after drug administration | 
| SpO2 | Oxygen saturation using pulse oximetry | Time1:0 minute after drug administration | 
| HR | Heart rate | Time2:0 minute after intubation | 
| DBP | Diastolic blood pressure | Time2:0 minute after intubation | 
| SBP | Systolic blood pressure | Time2:0 minute after intubation | 
| SpO2 | Oxygen saturation using pulse oximetry | Time2:0 minute after intubation | 
| HR | Heart rate | Time3:0 minute after medicine intervention | 
| DBP | Diastolic blood pressure | Time3:0 minute after medicine intervention | 
| SBP | Systolic blood pressure | Time3:0 minute after medicine intervention | 
| SpO2 | Oxygen saturation using pulse oximetry | Time3:0 minute after medicine intervention | 
| HR | Heart rate | Time4:0 minute after laryngectomy | 
| DBP | Diastolic blood pressure | Time4:0 minute after laryngectomy | 
| SBP | Systolic blood pressure | Time4:0 minute after laryngectomy | 
| SpO2 | Oxygen saturation using pulse oximetry | Time4:0 minute after laryngectomy | 
| HR | Heart rate | Time5:0 minute after the completion of surgery | 
| SBP | Systolic blood pressure | Time5:0 minute after the completion of surgery | 
| DBP | Diastolic blood pressure | Time5:0 minute after the completion of surgery | 
| SpO2 | Oxygen saturation using pulse oximetry | Time5:0 minute after the completion of surgery | 
| HR | Heart rate | Time6:0 minute after awareness | 
| SBP | Systolic blood pressure | Time6:0 minute after awareness | 
| DBP | Diastolic blood pressure | Time6:0 minute after awareness | 
| SpO2 | Oxygen saturation using pulse oximetry | Time6:0 minute after awareness | 
| HR | Heart rate | Time7:0 minute after departure from the PACU | 
| SBP | Systolic blood pressure | Time7:0 minute after departure from the PACU | 
| BDP | Diastolic blood pressure | Time7:0 minute after departure from the PACU | 
| SpO2 | Oxygen saturation using pulse oximetry | Time7:0 minute after departure from the PACU | 
| Pain intensity | Assessed by Visual Analogue Scale (VAS), (0, no pain; 10, the worst pain intolerable) | Time0:2hours after surgery | 
| Sedation | Assessed by Ramsay sedation scale (RSS),1, Anxious or restless or both,2, Cooperative, orientated and tranquil,3,Responding to commands,4,Brisk response to stimulus,5,Sluggish response to stimulus,6, No response to stimulus. | Time0: 2hours after surgery | 
| the incidence of adverse effects | desaturation,shivering,drowsiness, delirium,hypertension,hypotension,itching,arrhythmia,respiratory depression | Time0:2hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, midazolam, cough, sedation, pain