Clinical trial · Interventional
Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngectomy; Status | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexmedetomidine Injectable Product | Drug | — | UNRESOLVED |
| Midazolam injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- dexmedetomidine
- description
- patients receive dexmedetomidine infusion
- interventionNames
- Drug: Dexmedetomidine Injectable Product
- type
- EXPERIMENTAL
- label
- midazolam
- description
- patients receive midazolam infusion
- interventionNames
- Drug: Midazolam injection
Primary outcomes (1)
- measure
- The severity of cough
- timeFrame
- Time0:2hours after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDXu R, Zhu Y, Lu Y, Li W, Jia J. Dexmedetomidine versus midazolam on cough and recovery quality after partial and total laryngectomy - a randomized controlled trial. BMC Anesthesiol. 2020 Sep 28;20(1):249. doi: 10.1186/s12871-020-01168-7. PMID 32988369