Laryngectomy; Status
Conditions
Keywords
dexmedetomidine, midazolam, cough, sedation, pain
Brief summary
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.
Interventions
dexmedetomidine infusion at 0.5 µg•kg-1 for 10 min before tracheotomy then adjusted to 0.3µg•kg-1•h-1
DRUGMidazolam injection
midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-1
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
35 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The severity of cough | Time0:2hours after surgery | Coughing severity was classified using the 3-point scale.:1=mild (single) cough, 2=moderate (≤5 s) cough, and 3=severe (\>5 s) cough. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SBP | Time0: 0 minute after arriving the operation room | Systolic blood pressure |
| DBP | Time0: 0 minute after arriving the operation room | Diastolic blood pressure |
| SpO2 | Time0: 0 minute after arriving the operation room | Oxygen saturation using pulse oximetry |
| HR | Time0: 0 minute after arriving the operation room | Heart rate |
| Pain intensity | Time0:2hours after surgery | Assessed by Visual Analogue Scale (VAS), (0, no pain; 10, the worst pain intolerable) |
| Sedation | Time0: 2hours after surgery | 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. |
| the incidence of adverse effects | Time0:2hours after surgery | desaturation,shivering,drowsiness, delirium,hypertension,hypotension,itching,arrhythmia,respiratory depression |
| BDP | Time7:0 minute after departure from the PACU | Diastolic blood pressure |
Countries
China
Outcome results
None listed