Clinical trial NCT03918889: Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngectomy; Status
Keywords: dexmedetomidine
midazolam
cough
sedation
pain
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 120
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The severity of cough
timeFrame: Time0:2hours after surgery
Secondary outcomes:
measure: HR
timeFrame: Time0: 0 minute after arriving the operation room
measure: SBP
timeFrame: Time0: 0 minute after arriving the operation room
measure: DBP
timeFrame: Time0: 0 minute after arriving the operation room
measure: SpO2
timeFrame: Time0: 0 minute after arriving the operation room
measure: HR
timeFrame: Time1:0 minute after drug administration
measure: SBP
timeFrame: Time1:0 minute after drug administration
measure: DBP
timeFrame: Time1:0 minute after drug administration
measure: SpO2
timeFrame: Time1:0 minute after drug administration
measure: HR
timeFrame: Time2:0 minute after intubation
measure: DBP
timeFrame: Time2:0 minute after intubation
measure: SBP
timeFrame: Time2:0 minute after intubation
measure: SpO2
timeFrame: Time2:0 minute after intubation
measure: HR
timeFrame: Time3:0 minute after medicine intervention
measure: DBP
timeFrame: Time3:0 minute after medicine intervention
measure: SBP
timeFrame: Time3:0 minute after medicine intervention
measure: SpO2
timeFrame: Time3:0 minute after medicine intervention
measure: HR
timeFrame: Time4:0 minute after laryngectomy
measure: DBP
timeFrame: Time4:0 minute after laryngectomy
measure: SBP
timeFrame: Time4:0 minute after laryngectomy
measure: SpO2
timeFrame: Time4:0 minute after laryngectomy
measure: HR
timeFrame: Time5:0 minute after the completion of surgery
measure: SBP
timeFrame: Time5:0 minute after the completion of surgery
measure: DBP
timeFrame: Time5:0 minute after the completion of surgery
measure: SpO2
timeFrame: Time5:0 minute after the completion of surgery
measure: HR
timeFrame: Time6:0 minute after awareness
measure: SBP
timeFrame: Time6:0 minute after awareness
measure: DBP
timeFrame: Time6:0 minute after awareness
measure: SpO2
timeFrame: Time6:0 minute after awareness
measure: HR
timeFrame: Time7:0 minute after departure from the PACU
measure: SBP
timeFrame: Time7:0 minute after departure from the PACU
measure: BDP
timeFrame: Time7:0 minute after departure from the PACU
measure: SpO2
timeFrame: Time7:0 minute after departure from the PACU
measure: Pain intensity
timeFrame: Time0:2hours after surgery
measure: Sedation
timeFrame: Time0: 2hours after surgery
measure: the incidence of adverse effects
timeFrame: Time0:2hours after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthes iology, The Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai Medical College of Fudan University
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology
name: Wenxian Li, PhD
role: STUDY_DIRECTOR
References:
citation: Xu 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.