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Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer
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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: dexmedetomidine
patients receive dexmedetomidine infusion
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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
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Experimental: midazolam
patients receive midazolam infusion
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Drug: Midazolam injection
midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-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.
- HR [ Time Frame: Time0: 0 minute after arriving the operation room ]Heart rate
- SBP [ Time Frame: Time0: 0 minute after arriving the operation room ]Systolic blood pressure
- DBP [ Time Frame: Time0: 0 minute after arriving the operation room ]Diastolic blood pressure
- SpO2 [ Time Frame: Time0: 0 minute after arriving the operation room ]Oxygen saturation using pulse oximetry
- HR [ Time Frame: Time1:0 minute after drug administration ]Heart rate
- SBP [ Time Frame: Time1:0 minute after drug administration ]Systolic blood pressure
- DBP [ Time Frame: Time1:0 minute after drug administration ]Diastolic blood pressure
- SpO2 [ Time Frame: Time1:0 minute after drug administration ]Oxygen saturation using pulse oximetry
- HR [ Time Frame: Time2:0 minute after intubation ]Heart rate
- DBP [ Time Frame: Time2:0 minute after intubation ]Diastolic blood pressure
- SBP [ Time Frame: Time2:0 minute after intubation ]Systolic blood pressure
- SpO2 [ Time Frame: Time2:0 minute after intubation ]Oxygen saturation using pulse oximetry
- HR [ Time Frame: Time3:0 minute after medicine intervention ]Heart rate
- DBP [ Time Frame: Time3:0 minute after medicine intervention ]Diastolic blood pressure
- SBP [ Time Frame: Time3:0 minute after medicine intervention ]Systolic blood pressure
- SpO2 [ Time Frame: Time3:0 minute after medicine intervention ]Oxygen saturation using pulse oximetry
- HR [ Time Frame: Time4:0 minute after laryngectomy ]Heart rate
- DBP [ Time Frame: Time4:0 minute after laryngectomy ]Diastolic blood pressure
- SBP [ Time Frame: Time4:0 minute after laryngectomy ]Systolic blood pressure
- SpO2 [ Time Frame: Time4:0 minute after laryngectomy ]Oxygen saturation using pulse oximetry
- HR [ Time Frame: Time5:0 minute after the completion of surgery ]Heart rate
- SBP [ Time Frame: Time5:0 minute after the completion of surgery ]Systolic blood pressure
- DBP [ Time Frame: Time5:0 minute after the completion of surgery ]Diastolic blood pressure
- SpO2 [ Time Frame: Time5:0 minute after the completion of surgery ]Oxygen saturation using pulse oximetry
- HR [ Time Frame: Time6:0 minute after awareness ]Heart rate
- SBP [ Time Frame: Time6:0 minute after awareness ]Systolic blood pressure
- DBP [ Time Frame: Time6:0 minute after awareness ]Diastolic blood pressure
- SpO2 [ Time Frame: Time6:0 minute after awareness ]Oxygen saturation using pulse oximetry
- HR [ Time Frame: Time7:0 minute after departure from the PACU ]Heart rate
- SBP [ Time Frame: Time7:0 minute after departure from the PACU ]Systolic blood pressure
- BDP [ Time Frame: Time7:0 minute after departure from the PACU ]Diastolic blood pressure
- SpO2 [ Time Frame: Time7:0 minute after departure from the PACU ]Oxygen saturation using pulse oximetry
- Pain intensity [ Time Frame: Time0:2hours after surgery ]Assessed by Visual Analogue Scale (VAS), (0, no pain; 10, the worst pain intolerable)
- 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.
- the incidence of adverse effects [ Time Frame: Time0:2hours after surgery ]desaturation,shivering,drowsiness, delirium,hypertension,hypotension,itching,arrhythmia,respiratory depression
| Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
| 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 | |
| Study Director: | Wenxian Li, PhD | Department of Anesthesiology |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 28, 2019 | ||||
| First Posted Date ICMJE | April 18, 2019 | ||||
| Last Update Posted Date | January 18, 2020 | ||||
| Actual Study Start Date ICMJE | May 1, 2019 | ||||
| Estimated Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Laryngectomy; Status | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE |
120 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 1, 2020 | ||||
| Estimated Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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. |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 35 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03918889 | ||||
| Other Study ID Numbers ICMJE | 2013005 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Eye & ENT Hospital of Fudan University | ||||
| Study Sponsor ICMJE | Eye & ENT Hospital of Fudan University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Eye & ENT Hospital of Fudan University | ||||
| Verification Date | January 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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