- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915561
Effect of Intravenous Dynastat on Postoperative Sore Throat
April 10, 2019 updated by: Po-Kai Wang, Buddhist Tzu Chi General Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
140
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Po-Kai Wang, PhD
- Phone Number: 16238 +886-3-856-1825
- Email: pk8511034@yahoo.com.tw
Study Locations
-
-
Hualien
-
Hualien City, Hualien, Taiwan, 97002
- Recruiting
- Po-Kai Wang
-
Contact:
- Po-Kai Wang, PD
- Phone Number: 16238 +886-3-856-1825
- Email: pk8511034@yahoo.com.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Study group
This group will be received intravenous injection with 10ml transparent mixture solution with 40mg Dynastat and 0.9% saline twice
|
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.
Other Names:
|
Placebo Comparator: Placebo
This group will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice
|
Placebo group (0.9% saline, group S) will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 early incidence will be assessed between 1 and 2 hours after surgery
|
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
|
The late incidence will be assessed at 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The early severity of POST
Time Frame: The early severity of POST will be assessed between 1 and 2 hours after surgery
|
0 to 100, 0 = no POST at any time since the operation, and 100 = the most severe POST after the operation
|
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
|
0 to 100, 0 = no POST at any time since the operation, and 100 = the most severe POST after the operation
|
The late severity will be assessed at 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Po-Kai Wang, PhD, Buddhist Tzu Chi General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Hara 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.
- McHardy 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.
- El-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.
- Cheer SM, Goa KL. Parecoxib (parecoxib sodium). Drugs. 2001;61(8):1133-41; discussion 1142-3. doi: 10.2165/00003495-200161080-00010.
- Harris 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.
- Graff 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.
- Schug 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
November 30, 2020
Study Registration Dates
First Submitted
March 31, 2019
First Submitted That Met QC Criteria
April 10, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Postoperative Complications
- Pharyngitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Parecoxib
Other Study ID Numbers
- IRB108-27-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Complications
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainRecruitingComplications, PostoperativeUnited States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Wake Forest University Health SciencesTerminatedPerioperative/Postoperative ComplicationsUnited States
-
Technical University of MunichHealth Information Management, BelgiumActive, not recruitingPerioperative/Postoperative Complications
-
Atatürk Chest Diseases and Chest Surgery Training...CompletedPerioperative/Postoperative ComplicationsTurkey
-
Namigar TurgutCompletedPerioperative/Postoperative ComplicationsTurkey
-
TC Erciyes UniversityCompletedPerioperative/Postoperative ComplicationsTurkey
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
Clinical Trials on Parecoxib Injectable Product
-
Psoriasis Treatment Center of Central New JerseySun Pharmaceutical Industries LimitedUnknown
-
Tang-Du HospitalRecruitingMyasthenia Gravis, GeneralizedChina
-
Hospital Israelita Albert EinsteinMinistry of Health, BrazilCompletedSpinal Muscular AtrophyBrazil
-
National Taiwan University HospitalCompletedHepatitis A | Human Immunodeficiency Virus | Vaccine Response ImpairedTaiwan
-
Assiut UniversityCompletedOsteoarthritis Knees BothEgypt
-
University of VirginiaRegeneron PharmaceuticalsRecruiting
-
Cairo UniversityUnknown
-
Mercy Medical CenterRecruitingHepatitis B | Cirrhosis, Liver | Chronic Liver DiseaseUnited States
-
Nova Scotia Health AuthorityDalhousie UniversityActive, not recruiting