Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03918889
Recruitment Status : Enrolling by invitation
First Posted : April 18, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

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.


Condition or disease Intervention/treatment Phase
Laryngectomy; Status Drug: Dexmedetomidine Injectable Product Drug: Midazolam injection Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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




Primary Outcome Measures :
  1. The severity of cough [ Time Frame: Time0:2hours after surgery ]
    Coughing severity was classified using the 3-point scale.:1=mild (single) cough, 2=moderate (≤5 s) cough, and 3=severe (>5 s) cough.


Secondary Outcome Measures :
  1. HR [ Time Frame: Time0: 0 minute after arriving the operation room ]
    Heart rate

  2. SBP [ Time Frame: Time0: 0 minute after arriving the operation room ]
    Systolic blood pressure

  3. DBP [ Time Frame: Time0: 0 minute after arriving the operation room ]
    Diastolic blood pressure

  4. SpO2 [ Time Frame: Time0: 0 minute after arriving the operation room ]
    Oxygen saturation using pulse oximetry

  5. HR [ Time Frame: Time1:0 minute after drug administration ]
    Heart rate

  6. SBP [ Time Frame: Time1:0 minute after drug administration ]
    Systolic blood pressure

  7. DBP [ Time Frame: Time1:0 minute after drug administration ]
    Diastolic blood pressure

  8. SpO2 [ Time Frame: Time1:0 minute after drug administration ]
    Oxygen saturation using pulse oximetry

  9. HR [ Time Frame: Time2:0 minute after intubation ]
    Heart rate

  10. DBP [ Time Frame: Time2:0 minute after intubation ]
    Diastolic blood pressure

  11. SBP [ Time Frame: Time2:0 minute after intubation ]
    Systolic blood pressure

  12. SpO2 [ Time Frame: Time2:0 minute after intubation ]
    Oxygen saturation using pulse oximetry

  13. HR [ Time Frame: Time3:0 minute after medicine intervention ]
    Heart rate

  14. DBP [ Time Frame: Time3:0 minute after medicine intervention ]
    Diastolic blood pressure

  15. SBP [ Time Frame: Time3:0 minute after medicine intervention ]
    Systolic blood pressure

  16. SpO2 [ Time Frame: Time3:0 minute after medicine intervention ]
    Oxygen saturation using pulse oximetry

  17. HR [ Time Frame: Time4:0 minute after laryngectomy ]
    Heart rate

  18. DBP [ Time Frame: Time4:0 minute after laryngectomy ]
    Diastolic blood pressure

  19. SBP [ Time Frame: Time4:0 minute after laryngectomy ]
    Systolic blood pressure

  20. SpO2 [ Time Frame: Time4:0 minute after laryngectomy ]
    Oxygen saturation using pulse oximetry

  21. HR [ Time Frame: Time5:0 minute after the completion of surgery ]
    Heart rate

  22. SBP [ Time Frame: Time5:0 minute after the completion of surgery ]
    Systolic blood pressure

  23. DBP [ Time Frame: Time5:0 minute after the completion of surgery ]
    Diastolic blood pressure

  24. SpO2 [ Time Frame: Time5:0 minute after the completion of surgery ]
    Oxygen saturation using pulse oximetry

  25. HR [ Time Frame: Time6:0 minute after awareness ]
    Heart rate

  26. SBP [ Time Frame: Time6:0 minute after awareness ]
    Systolic blood pressure

  27. DBP [ Time Frame: Time6:0 minute after awareness ]
    Diastolic blood pressure

  28. SpO2 [ Time Frame: Time6:0 minute after awareness ]
    Oxygen saturation using pulse oximetry

  29. HR [ Time Frame: Time7:0 minute after departure from the PACU ]
    Heart rate

  30. SBP [ Time Frame: Time7:0 minute after departure from the PACU ]
    Systolic blood pressure

  31. BDP [ Time Frame: Time7:0 minute after departure from the PACU ]
    Diastolic blood pressure

  32. SpO2 [ Time Frame: Time7:0 minute after departure from the PACU ]
    Oxygen saturation using pulse oximetry

  33. Pain intensity [ Time Frame: Time0:2hours after surgery ]
    Assessed by Visual Analogue Scale (VAS), (0, no pain; 10, the worst pain intolerable)

  34. Sedation [ Time Frame: Time0: 2hours after surgery ]
    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.

  35. the incidence of adverse effects [ Time Frame: Time0:2hours after surgery ]
    desaturation,shivering,drowsiness, delirium,hypertension,hypotension,itching,arrhythmia,respiratory depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918889


Locations
Layout table for location information
China, Shanghai
Department of Anesthes iology, The Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai Medical College of Fudan University
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University
Investigators
Layout table for investigator information
Study Director: Wenxian Li, PhD Department of Anesthesiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03918889    
Other Study ID Numbers: 2013005
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eye & ENT Hospital of Fudan University:
dexmedetomidine
midazolam
cough
sedation
pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents