Sore ThroatPhase 2NCT03915561
Effect of Intravenous Dynastat on Postoperative Sore Throat
A Phase 2 study testing Parecoxib Injectable Product and Normal saline in people with Sore Throat and Postoperative Complications, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
A postoperative sore throat (POST) after tracheal intubation is one of the most common postoperative problems causing dissatisfaction to participants, including sore throat, dry throat, cough, sputum, hoarseness and even dysphagia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sore Throat, Postoperative Complications
- What is being tested?
- Parecoxib Injectable Product and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 30 Nov 2020
- Phase
- Phase 2
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status 1 and 2
- Requiring general anesthesia with endotracheal intubation (ETGA) for elective non-cardiac surgery
- The anesthetic time after intubation will need 90 minutes at least.
Who cannot join
- Those with a preexisting cough, hoarseness or a sore throat
- Smoker
- History of asthma or chronic obstructive pulmonary disorder
- Vocal performer by occupation
- Recent or recurrent respiratory tract infection
- Risk factors for postoperative aspiration, for example obesity, pregnancy
Show all 18Show fewer
- Allergic reaction to Dynastat, acetylsalicylic acid, sulfonamide or NSAIDs.
- Active GI bleeding or gastric ulcer
- Third trimester and during lactation
- Anticipated difficult intubation
- Mallampati grade >2
- Difficult mask ventilation requiring oral or nasal airway
- Cormack and Lehane grade III and IV on laryngoscopy
- Intubation attempt >1
- Moderate to severe liver dysfunction (Child-Pugh score >7)
- Severe renal dysfunction (Ccr < 30 ml/min)
- Congestive heart failure (NYHA II-IV)
- Those requiring orogastric or nasogastric tubes
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Po-Kai Wang
Hualien City, Hualien, 97002
Po-Kai Wang, PD, +886-3-856-1825 ext. 16238, pk8511034@yahoo.com.tw
About this study
Official title: Effect of Intravenous Dynastat on Postoperative Sore Throat: A Randomized Double-blinded Controlled Trial
A postoperative sore throat (POST) after tracheal intubation is one of the most common postoperative problems causing dissatisfaction to participants, including sore throat, dry throat, cough, sputum, hoarseness and even dysphagia. Both nonpharmacological and pharmacological measures have been attempted to alleviate the incidence and severity of POST with variable success. Airway inflammation may be important in the pathogenesis of these symptoms in intubated participants but however, there was still no study to investigate the effect of cyclooxygenase-2 (COX-2) for the prevention of POST. So, the investigators' study will be the first one to investigate if perioperatively intravenous (IV) Dynastat injection can be used as a new indication for POST prevention.
Read the detailed description
The investigators' study will be designed a two-arm, individually randomized, double-blind, placebo-controlled trial comparing two doses of 40mg Dynastat with placebo (0.9% saline) in participants who will receive noncardiac surgery under general anesthesia with tracheal intubation. The investigators will include participants of American Society of Anesthesiologists physical status 1 and 2, 20-65 years of age, requiring general anesthesia with endotracheal intubation (ETGA) for elective non-cardiac surgery will be enrolled. Besides, the anesthetic time after intubation will need 90 minutes at least. Those with a preexisting cough, hoarseness or a sore throat, smoker, history of asthma or chronic obstructive pulmonary disorder, vocal performer by occupation, recent or recurrent respiratory tract infection, risk factors for postoperative aspiration, obesity, pregnancy, and contraindication to Dynastat medications will be excluded. Anticipated difficult intubation, Mallampati grade >2, difficult mask ventilation requiring oral or nasal airway, Cormack and Lehane grade III and IV on laryngoscopy, intubation attempt >1, moderate to severe liver dysfunction (Child-Pugh score >7), severe renal dysfunction (Ccr < 30 ml/min), congestive heart failure (NYHA II-IV), and those requiring orogastric or nasogastric tubes will be other exclusion criteria. In the operating room, participants will receive study drug according to the group allocation. General anesthesia will be induced with IV fentanyl 2 μg/kg and propofol 2 mg/kg, followed by rocuronium 0.8 mg/kg. After achieving adequate time of neuromuscular blockade onset, an anesthesiologist (endotracheal tube intubation numbers > 500 times), unaware of the group allocation, will perform laryngoscopy in all the groups using standard 3 or 4 Macintosh blades. Polyvinylchloride endotracheal tubes (ETTs) with a 7-mm ID for male and 6.5-mm ID for female will be used for orotracheal intubation. Lubrication will be applied on the ETT. The cuff will be inflated with air to the point just capable of sealing leakage. The cuff pressure will be checked and adjusted to 25-30 cmH2O with the help of pressure gauge. At the end of surgery, the residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg. Gentle suctioning of oral secretions will be done with 12F soft suction catheter while limiting the suction pressure to 50 cmH2O before tracheal extubation. After tracheal extubation, participants will be transferred to the postanesthetic care unit. The following variables at the time of tracheal intubation and extubation will be recorded: Cormack and Lehane laryngoscopy score; resistance to ETT insertion (none/mild/moderate); the time to achieve intubation will be defined as the time from opening of mouth for insertion of laryngoscope blade to confirmed placement of ETT (assessed with chest auscultation and capnograph); application of external laryngeal pressure to aid endotracheal intubation; duration of tracheal intubation defined as the time from placement of ETT to its removal; repositioning of ETT; blood tinge on the suction catheter during oral suctioning; blood stain on ET after its removal; and total opioid consumption in the postoperative period. The investigators' primary subject will be the incidence of POST, and the main effects of Dynastat will be the primary interest. The incidence of POST will be also compared among the 2 groups. Secondary outcomes included the severity of POST, incidences and severity of cough, hoarseness, and dysphagia.
- Conditions
- Sore Throat, Postoperative Complications
- Being tested
- Parecoxib Injectable Product, Normal saline
- Keywords
- postoperative sore throat
- Medical subject headings
- Pharyngitis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib Injectable ProductDrug
Also called Dynastat
Dynastat (parecoxib sodium) is rapidly converted to valdecoxib following injection and reduces the production of prostaglandins that are important mediators of pain and inflammation. After intravenous injection with 40mg Dynastat, the onset of analgesia was 7-14 minutes and reached a peak effect within 2 hours. After a single dose, the duration of analgesia was dose and clinical pain model dependent and ranged from 6 to greater than 24 hours and maximal daily dose of Dynastat is 80mg. According to recommendation of acute postoperative pain management and product information, the timing of first injection will be at 10 minutes before anesthetic induction, and second injection will be 6 to 12 hours after first injection.
Normal salineDrug
Placebo group (0.9% saline, group S) will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | This group will be received intravenous injection with 10ml transparent mixture solution with 40mg Dynastat and 0.9% saline twice Receives: Drug: Parecoxib Injectable Product |
| Placebo | Placebo comparator | This group will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The early incidence of POST
The early incidence of POST will be also compared among the 2 groups
Measured: The early incidence will be assessed between 1 and 2 hours after surgery
The late incidence of POST
The late incidence of POST will be also compared among the 2 groups
Measured: The late incidence will be assessed at 24 hours after surgery
Secondary outcomes (2)
The early severity of POST
0 to 100, 0 = no POST at any time since the operation, and 100 = the most severe POST after the operation
Measured: The early severity of POST will be assessed between 1 and 2 hours after surgery
The late severity of POST
0 to 100, 0 = no POST at any time since the operation, and 100 = the most severe POST after the operation
Measured: The late severity will be assessed at 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a two-arm, individually randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Po-Kai Wang, Buddhist Tzu Chi General Hospital
- Investigators
- Po-Kai Wang, PhD, Principal investigator, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915561
- Sponsor's protocol ID
- IRB108-27-A
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
PubMed 26171894Hara K, Maruyama K. Effect of additives in lidocaine spray on postoperative sore throat, hoarseness and dysphagia after total intravenous anaesthesia. Acta Anaesthesiol Scand. 2005 Apr;49(4):463-7. doi: 10.1111/j.1399-6576.2005.00632.x.
PubMed 15777293McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53. doi: 10.1046/j.1365-2044.1999.00780.x.
PubMed 10995141El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
PubMed 27158989Cheer SM, Goa KL. Parecoxib (parecoxib sodium). Drugs. 2001;61(8):1133-41; discussion 1142-3. doi: 10.2165/00003495-200161080-00010.
PubMed 11465874Harris SI, Stoltz RR, LeComte D, Hubbard RC. Parecoxib sodium demonstrates gastrointestinal safety comparable to placebo in healthy subjects. J Clin Gastroenterol. 2004 Aug;38(7):575-80. doi: 10.1097/00004836-200408000-00007.
PubMed 15232360Graff J, Arabmotlagh M, Cheung R, Geisslinger G, Harder S. Effects of parecoxib and dipyrone on platelet aggregation in patients undergoing meniscectomy: a double-blind, randomized, parallel-group study. Clin Ther. 2007 Mar;29(3):438-47. doi: 10.1016/s0149-2918(07)80082-8.
PubMed 17577465Schug SA, Joshi GP, Camu F, Pan S, Cheung R. Cardiovascular safety of the cyclooxygenase-2 selective inhibitors parecoxib and valdecoxib in the postoperative setting: an analysis of integrated data. Anesth Analg. 2009 Jan;108(1):299-307. doi: 10.1213/ane.0b013e31818ca3ac.
PubMed 19095866
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dynastat on Postoperative Sore Throat: A Randomized Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT03915561
- Acronym / sponsor ID
- IRB108-27-A
- Conditions
- Sore Throat, Postoperative Complications
- Keywords
- postoperative sore throat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A postoperative sore throat (POST) after tracheal intubation is one of the most common postoperative problems causing dissatisfaction to participants, including sore throat, dry throat, cough, sputum, hoarseness and even dysphagia. Both nonpharmacological and pharmacological measures have been attempted to alleviate the incidence and severity of POST with variable success. Airway inflammation may be important in the pathogenesis of these symptoms in intubated participants but however, there was still no study to investigate the effect of cyclooxygenase-2 (COX-2) for the prevention of POST. So, the investigators' study will be the first one to investigate if perioperatively intravenous (IV) Dynastat injection can be used as a new indication for POST prevention.
Detailed description
The investigators' study will be designed a two-arm, individually randomized, double-blind, placebo-controlled trial comparing two doses of 40mg Dynastat with placebo (0.9% saline) in participants who will receive noncardiac surgery under general anesthesia with tracheal intubation. The investigators will include participants of American Society of Anesthesiologists physical status 1 and 2, 20-65 years of age, requiring general anesthesia with endotracheal intubation (ETGA) for elective non-cardiac surgery will be enrolled. Besides, the anesthetic time after intubation will need 90 minutes at least. Those with a preexisting cough, hoarseness or a sore throat, smoker, history of asthma or chronic obstructive pulmonary disorder, vocal performer by occupation, recent or recurrent respiratory tract infection, risk factors for postoperative aspiration, obesity, pregnancy, and contraindication to Dynastat medications will be excluded. Anticipated difficult intubation, Mallampati grade >2, difficult mask ventilation requiring oral or nasal airway, Cormack and Lehane grade III and IV on laryngoscopy, intubation attempt >1, moderate to severe liver dysfunction (Child-Pugh score >7), severe renal dysfunction (Ccr < 30 ml/min), congestive heart failure (NYHA II-IV), and those requiring orogastric or nasogastric tubes will be other exclusion criteria. In the operating room, participants will receive study drug according to the group allocation. General anesthesia will be induced with IV fentanyl 2 μg/kg and propofol 2 mg/kg, followed by rocuronium 0.8 mg/kg. After achieving adequate time of neuromuscular blockade onset, an anesthesiologist (endotracheal tube intubation numbers > 500 times), unaware of the group allocation, will perform laryngoscopy in all the groups using standard 3 or 4 Macintosh blades. Polyvinylchloride endotracheal tubes (ETTs) with a 7-mm ID for male and 6.5-mm ID for female will be used for orotracheal intubation. Lubrication will be applied on the ETT. The cuff will be inflated with air to the point just capable of sealing leakage. The cuff pressure will be checked and adjusted to 25-30 cmH2O with the help of pressure gauge. At the end of surgery, the residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg. Gentle suctioning of oral secretions will be done with 12F soft suction catheter while limiting the suction pressure to 50 cmH2O before tracheal extubation. After tracheal extubation, participants will be transferred to the postanesthetic care unit. The following variables at the time of tracheal intubation and extubation will be recorded: Cormack and Lehane laryngoscopy score; resistance to ETT insertion (none/mild/moderate); the time to achieve intubation will be defined as the time from opening of mouth for insertion of laryngoscope blade to confirmed placement of ETT (assessed with chest auscultation and capnograph); application of external laryngeal pressure to aid endotracheal intubation; duration of tracheal intubation defined as the time from placement of ETT to its removal; repositioning of ETT; blood tinge on the suction catheter during oral suctioning; blood stain on ET after its removal; and total opioid consumption in the postoperative period. The investigators' primary subject will be the incidence of POST, and the main effects of Dynastat will be the primary interest. The incidence of POST will be also compared among the 2 groups. Secondary outcomes included the severity of POST, incidences and severity of cough, hoarseness, and dysphagia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a two-arm, individually randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Drug: Parecoxib Injectable ProductThis group will be received intravenous injection with 10ml transparent mixture solution with 40mg Dynastat and 0.9% saline twice |
| Placebo | Placebo comparator | Drug: Normal salineThis group will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status 1 and 2
- Requiring general anesthesia with endotracheal intubation (ETGA) for elective non-cardiac surgery
- The anesthetic time after intubation will need 90 minutes at least.
Key exclusion criteria (18 listed)
- Those with a preexisting cough, hoarseness or a sore throat
- Smoker
- History of asthma or chronic obstructive pulmonary disorder
- Vocal performer by occupation
- Recent or recurrent respiratory tract infection
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 |
|---|---|---|
| Parecoxib Injectable ProductAlso: DynastatDynastat (parecoxib sodium) is rapidly converted to valdecoxib following injection and reduces the production of prostaglandins that are important mediators of pain and inflammation. After intravenous injection with 40mg Dynastat, the onset of analgesia was 7-14 minutes and reached a peak effect within 2 hours. After a single dose, the duration of analgesia was dose and clinical pain model dependent and ranged from 6 to greater than 24 hours and maximal daily dose of Dynastat is 80mg. According to recommendation of acute postoperative pain management and product information, the timing of first injection will be at 10 minutes before anesthetic induction, and second injection will be 6 to 12 hours after first injection. | Drug | Study group |
| Normal salinePlacebo group (0.9% saline, group S) will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice. | Drug | Placebo |
Primary outcome
The early incidence of POST
Time frame: The early incidence will be assessed between 1 and 2 hours after surgery
The early incidence of POST will be also compared among the 2 groups
The late incidence of POST
Time frame: The late incidence will be assessed at 24 hours after surgery
The late incidence of POST will be also compared among the 2 groups
2 secondary outcomes
The early severity of POST
Time frame: The early severity of POST will be assessed between 1 and 2 hours after surgery
The late severity of POST
Time frame: The late severity will be assessed at 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Results publication: PubMed 26171894Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
- Results publication: PubMed 15777293Hara K, Maruyama K. Effect of additives in lidocaine spray on postoperative sore throat, hoarseness and dysphagia after total intravenous anaesthesia. Acta Anaesthesiol Scand. 2005 Apr;49(4):463-7. doi: 10.1111/j.1399-6576.2005.00632.x.
- Results publication: PubMed 10995141McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53. doi: 10.1046/j.1365-2044.1999.00780.x.
- Results publication: PubMed 27158989El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
- Results publication: PubMed 11465874Cheer SM, Goa KL. Parecoxib (parecoxib sodium). Drugs. 2001;61(8):1133-41; discussion 1142-3. doi: 10.2165/00003495-200161080-00010.
- Results publication: PubMed 15232360Harris SI, Stoltz RR, LeComte D, Hubbard RC. Parecoxib sodium demonstrates gastrointestinal safety comparable to placebo in healthy subjects. J Clin Gastroenterol. 2004 Aug;38(7):575-80. doi: 10.1097/00004836-200408000-00007.
- Results publication: PubMed 17577465Graff J, Arabmotlagh M, Cheung R, Geisslinger G, Harder S. Effects of parecoxib and dipyrone on platelet aggregation in patients undergoing meniscectomy: a double-blind, randomized, parallel-group study. Clin Ther. 2007 Mar;29(3):438-47. doi: 10.1016/s0149-2918(07)80082-8.
- Results publication: PubMed 19095866Schug SA, Joshi GP, Camu F, Pan S, Cheung R. Cardiovascular safety of the cyclooxygenase-2 selective inhibitors parecoxib and valdecoxib in the postoperative setting: an analysis of integrated data. Anesth Analg. 2009 Jan;108(1):299-307. doi: 10.1213/ane.0b013e31818ca3ac.
- Individual participant dataSharing planned: No
Related trials for Sore Throat
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
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.
Po-Kai Wang, PhD principal investigator
Buddhist Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parecoxib Injectable Product and Normal saline in people with Sore Throat and Postoperative Complications, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 3 inclusion and 18 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 16 Apr 2019. 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Po-Kai Wang, PhD (+886-3-856-1825 ext. 16238, pk8511034@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The early incidence of POST (time frame: The early incidence will be assessed between 1 and 2 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT03915561, which also lists 8 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 16 Apr 2019.