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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-12-01

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.

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Detailed Description

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Conditions

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Laryngectomy; Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine

patients receive dexmedetomidine infusion

Group Type EXPERIMENTAL

Dexmedetomidine Injectable Product

Intervention Type DRUG

dexmedetomidine infusion at 0.5 µg•kg-1 for 10 min before tracheotomy then adjusted to 0.3µg•kg-1•h-1

midazolam

patients receive midazolam infusion

Group Type EXPERIMENTAL

Midazolam injection

Intervention Type DRUG

midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-1

Interventions

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Dexmedetomidine Injectable Product

dexmedetomidine infusion at 0.5 µg•kg-1 for 10 min before tracheotomy then adjusted to 0.3µg•kg-1•h-1

Intervention Type DRUG

Midazolam injection

midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-1

Intervention Type DRUG

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No