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

Laryngectomy; Status Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03918889
• Other study ID #: 2013005
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2020
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Laryngectomy; Status

Intervention

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

Locations

Country	Name	City	State
China	Department of Anesthes iology, The Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai Medical College of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HR	Heart rate	Time0: 0 minute after arriving the operation room
Secondary	SBP	Systolic blood pressure	Time0: 0 minute after arriving the operation room
Secondary	DBP	Diastolic blood pressure	Time0: 0 minute after arriving the operation room
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time0: 0 minute after arriving the operation room
Secondary	HR	Heart rate	Time1:0 minute after drug administration
Secondary	SBP	Systolic blood pressure	Time1:0 minute after drug administration
Secondary	DBP	Diastolic blood pressure	Time1:0 minute after drug administration
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time1:0 minute after drug administration
Secondary	HR	Heart rate	Time2:0 minute after intubation
Secondary	DBP	Diastolic blood pressure	Time2:0 minute after intubation
Secondary	SBP	Systolic blood pressure	Time2:0 minute after intubation
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time2:0 minute after intubation
Secondary	HR	Heart rate	Time3:0 minute after medicine intervention
Secondary	DBP	Diastolic blood pressure	Time3:0 minute after medicine intervention
Secondary	SBP	Systolic blood pressure	Time3:0 minute after medicine intervention
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time3:0 minute after medicine intervention
Secondary	HR	Heart rate	Time4:0 minute after laryngectomy
Secondary	DBP	Diastolic blood pressure	Time4:0 minute after laryngectomy
Secondary	SBP	Systolic blood pressure	Time4:0 minute after laryngectomy
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time4:0 minute after laryngectomy
Secondary	HR	Heart rate	Time5:0 minute after the completion of surgery
Secondary	SBP	Systolic blood pressure	Time5:0 minute after the completion of surgery
Secondary	DBP	Diastolic blood pressure	Time5:0 minute after the completion of surgery
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time5:0 minute after the completion of surgery
Secondary	HR	Heart rate	Time6:0 minute after awareness
Secondary	SBP	Systolic blood pressure	Time6:0 minute after awareness
Secondary	DBP	Diastolic blood pressure	Time6:0 minute after awareness
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time6:0 minute after awareness
Secondary	HR	Heart rate	Time7:0 minute after departure from the PACU
Secondary	SBP	Systolic blood pressure	Time7:0 minute after departure from the PACU
Secondary	BDP	Diastolic blood pressure	Time7:0 minute after departure from the PACU
Secondary	SpO2	Oxygen saturation using pulse oximetry	Time7:0 minute after departure from the PACU
Secondary	Pain intensity	Assessed by Visual Analogue Scale (VAS), (0, no pain; 10, the worst pain intolerable)	Time0:2hours after surgery
Secondary	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
Secondary	the incidence of adverse effects	desaturation,shivering,drowsiness, delirium,hypertension,hypotension,itching,arrhythmia,respiratory depression	Time0:2hours after surgery