Benign Neoplasm of Vocal Fold - GlottisNCT02108171
Intranasal Dexmedetomidine Premedication
A study testing Dexmedetomidine in people with Benign Neoplasm of Vocal Fold - Glottis, run by Guangzhou First People's Hospital at 2 sites in China.
Trial summary
Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Benign Neoplasm of Vocal Fold - Glottis
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Surgery:The laryngoscope vocal polyp excision
- Aged 18 to 60 years old
- Body mass index (BMI) < 30 kg/m2
- American society of Anesthesiologist (ASA) I -II
Who cannot join
- The investigator refused to participate
- Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
- With previous history of heart disease
- Pregnant women; no reliable contraceptive measures in postmenopausal women
- Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
- Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
Show all 11Show fewer
- Asthma
- Sleep apnea syndrome
- Liver and kidney dysfunction
- Known to suffer from mental illness
- Long-term use of sedatives and analgesics in patients
Trial locations and contacts
2 sites in 1 country.
China2 sites
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, 510180
Guangzhou First Municipal People's Hospital
Guangzhou, 510180
About this study
Official title: A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy
Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.
Read the detailed description
All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.
- Conditions
- Benign Neoplasm of Vocal Fold - Glottis
- Being tested
- Dexmedetomidine, placebo
- Keywords
- intranasal, dexmedetomidine, early recovery, suspension laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called intranasal dexmedetomidine
intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.
placeboDrug
Also called saline
0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | intranasal dexmedetomidine Receives: Drug: Dexmedetomidine |
| placebo | Placebo comparator | intranasal saline Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Time After Intranasal Dexmedetomidine Premedication
The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration
Measured: 1 days
Secondary outcomes (10)
Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine
Modified Observer's Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine.
Modified Observer's Assessment of Alertness/Sedation Scale:
6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking
1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus.
Measured: 1 days
Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine
Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.
Measured: 1 day
Number of Participants With Anxiety Score >2
satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction.
Anxiety score >2 was considered to be better for the patient.
Measured: 1 day
Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine
4-point anxiety score:
- = combative
- = anxious
- = calm
- = amiable. Anxiety score >2 was considered to be better for the preoperative patients.
Measured: 1 day
Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine
Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine.
Measured: 1 day
Number of Participants With Satisfaction Score <2
Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU).
Satisfaction score <2 was considered to be better for the patient
Measured: 1 day
Perioperative Bradycardia Episodes
Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s.
Measured: 1 day
Perioperative Tachycardia Episodes
Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s.
Measured: 1 day
Perioperative Hypotension Episodes
Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.
Measured: 1 day
Perioperative Hypertonsion Episodes
Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Benign Neoplasm of Vocal Fold - GlottisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital
- Investigators
- Xiangcai Ruan, MD, PHD, Principal investigator, Guangzhou First Municipal People's Hospital,Guangzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108171
- Sponsor's protocol ID
- GZFPH-IRB-2013-086
- Status last verified
- Feb 2016
- First submitted
- 30 Mar 2014
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
PubMed 24237879Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
PubMed 17646493Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
PubMed 22950484Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.
PubMed 21685111Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12.
PubMed 21318594Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.
PubMed 23497981Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.
PubMed 23325950Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.
PubMed 20645951Lu C, Zhang LM, Zhang Y, Ying Y, Li L, Xu L, Ruan X. Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study. PLoS One. 2016 May 19;11(5):e0154192. doi: 10.1371/journal.pone.0154192. eCollection 2016.
PubMed 27196121
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy
- ClinicalTrials.gov ID
- NCT02108171
- Acronym / sponsor ID
- GZFPH-IRB-2013-086
- Conditions
- Benign Neoplasm of Vocal Fold - Glottis
- Keywords
- intranasal, dexmedetomidine, early recovery, suspension laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.
Detailed description
All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: Dexmedetomidineintranasal dexmedetomidine |
| placebo | Placebo comparator | Drug: placebointranasal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Surgery:The laryngoscope vocal polyp excision
- Aged 18 to 60 years old
- Body mass index (BMI) < 30 kg/m2
- American society of Anesthesiologist (ASA) I -II
Key exclusion criteria (11 listed)
- The investigator refused to participate
- Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
- With previous history of heart disease
- Pregnant women; no reliable contraceptive measures in postmenopausal women
- Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: intranasal dexmedetomidineintranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia. | Drug | dexmedetomidine |
| placeboAlso: saline0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia. | Drug | placebo |
Primary outcome
Extubation Time After Intranasal Dexmedetomidine Premedication
Time frame: 1 days
The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration
10 secondary outcomes
Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine
Time frame: 1 days
Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine
Time frame: 1 day
Number of Participants With Anxiety Score >2
Time frame: 1 day
Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine
Time frame: 1 day
Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine
Time frame: 1 day
Number of Participants With Satisfaction Score <2
Time frame: 1 day
Perioperative Bradycardia Episodes
Time frame: 1 day
Perioperative Tachycardia Episodes
Time frame: 1 day
Perioperative Hypotension Episodes
Time frame: 1 day
Perioperative Hypertonsion Episodes
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24237879Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
- Background: PubMed 17646493Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
- Background: PubMed 22950484Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
- Background: PubMed 21685111Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.
- Background: PubMed 21318594Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12.
- Background: PubMed 23497981Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.
- Background: PubMed 23325950Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.
- Background: PubMed 20645951Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.
- Derived from this study: PubMed 27196121Lu C, Zhang LM, Zhang Y, Ying Y, Li L, Xu L, Ruan X. Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study. PLoS One. 2016 May 19;11(5):e0154192. doi: 10.1371/journal.pone.0154192. eCollection 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangcai Ruan, MD, PHD principal investigator
Guangzhou First Municipal People's Hospital,Guangzhou Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Benign Neoplasm of Vocal Fold - Glottis, run by Guangzhou First People's Hospital at 2 sites 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extubation Time After Intranasal Dexmedetomidine Premedication (time frame: 1 days). 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 NCT02108171, which also lists 9 linked publications.
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 14 Mar 2016.