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

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.

Study Overview

• Status: Unknown
• Conditions: Laryngectomy; Status
• Intervention / Treatment: Drug: Dexmedetomidine Injectable Product; Drug: Midazolam injection

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Department of Anesthes iology, The Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai Medical College of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: dexmedetomidine; patients receive dexmedetomidine infusion	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
EXPERIMENTAL: midazolam; patients receive midazolam infusion	Drug: Midazolam injection; midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Study Director: Wenxian Li, PhD, Department of Anesthesiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (ACTUAL): April 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pain; midazolam; dexmedetomidine; sedation; cough
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 2013005 (Other Grant/Funding Number: Clinical Research Program 5010 of Sun Yat-sen University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No