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Laryngectomy; StatusNCT03918889

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

A study testing Dexmedetomidine Injectable Product and Midazolam injection in people with Laryngectomy; Status, run by Eye & ENT Hospital of Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 65 years, men only
Conditions the study is for
Laryngectomy; Status
What is being tested?
Dexmedetomidine Injectable Product and Midazolam injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 May 2019to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject scheduled for partial or total laryngectomy.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

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

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.

Being tested
Dexmedetomidine Injectable Product, Midazolam injection
Keywords
dexmedetomidine, midazolam, cough, sedation, pain
Medical subject headings
Cough, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine Injectable ProductDrug

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

  • Midazolam injectionDrug

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

Study groups in NCT03918889
Study groupRoleWhat they receive
dexmedetomidineExperimentalpatients receive dexmedetomidine infusion
Receives: Drug: Dexmedetomidine Injectable Product
midazolamExperimentalpatients receive midazolam infusion
Receives: Drug: Midazolam injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Time0:2hours after surgery

Secondary outcomes (35)

  1. HR

    Heart rate

    Measured: Time0: 0 minute after arriving the operation room

  2. SBP

    Systolic blood pressure

    Measured: Time0: 0 minute after arriving the operation room

  3. DBP

    Diastolic blood pressure

    Measured: Time0: 0 minute after arriving the operation room

  4. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time0: 0 minute after arriving the operation room

  5. HR

    Heart rate

    Measured: Time1:0 minute after drug administration

  6. SBP

    Systolic blood pressure

    Measured: Time1:0 minute after drug administration

  7. DBP

    Diastolic blood pressure

    Measured: Time1:0 minute after drug administration

  8. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time1:0 minute after drug administration

  9. HR

    Heart rate

    Measured: Time2:0 minute after intubation

  10. DBP

    Diastolic blood pressure

    Measured: Time2:0 minute after intubation

  11. SBP

    Systolic blood pressure

    Measured: Time2:0 minute after intubation

  12. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time2:0 minute after intubation

  13. HR

    Heart rate

    Measured: Time3:0 minute after medicine intervention

  14. DBP

    Diastolic blood pressure

    Measured: Time3:0 minute after medicine intervention

  15. SBP

    Systolic blood pressure

    Measured: Time3:0 minute after medicine intervention

  16. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time3:0 minute after medicine intervention

  17. HR

    Heart rate

    Measured: Time4:0 minute after laryngectomy

  18. DBP

    Diastolic blood pressure

    Measured: Time4:0 minute after laryngectomy

  19. SBP

    Systolic blood pressure

    Measured: Time4:0 minute after laryngectomy

  20. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time4:0 minute after laryngectomy

  21. HR

    Heart rate

    Measured: Time5:0 minute after the completion of surgery

  22. SBP

    Systolic blood pressure

    Measured: Time5:0 minute after the completion of surgery

  23. DBP

    Diastolic blood pressure

    Measured: Time5:0 minute after the completion of surgery

  24. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time5:0 minute after the completion of surgery

  25. HR

    Heart rate

    Measured: Time6:0 minute after awareness

  26. SBP

    Systolic blood pressure

    Measured: Time6:0 minute after awareness

  27. DBP

    Diastolic blood pressure

    Measured: Time6:0 minute after awareness

  28. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time6:0 minute after awareness

  29. HR

    Heart rate

    Measured: Time7:0 minute after departure from the PACU

  30. SBP

    Systolic blood pressure

    Measured: Time7:0 minute after departure from the PACU

  31. BDP

    Diastolic blood pressure

    Measured: Time7:0 minute after departure from the PACU

  32. SpO2

    Oxygen saturation using pulse oximetry

    Measured: Time7:0 minute after departure from the PACU

  33. Pain intensity

    Assessed by Visual Analogue Scale (VAS), (0, no pain; 10, the worst pain intolerable)

    Measured: Time0:2hours after surgery

  34. 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.

    Measured: Time0: 2hours after surgery

  35. the incidence of adverse effects

    desaturation,shivering,drowsiness, delirium,hypertension,hypotension,itching,arrhythmia,respiratory depression

    Measured: Time0:2hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start1 May 2019
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03918889
Sponsor's protocol ID
2013005
Status last verified
Jan 2020
First submitted
28 Mar 2019
Last updated
18 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32988369

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine Injectable Product and Midazolam injection in people with Laryngectomy; Status, run by Eye & ENT Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The severity of cough (time frame: Time0:2hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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