Effect of Intravenous Dynastat on Postoperative Sore Throat
Effect of Intravenous Dynastat on Postoperative Sore Throat: A Randomized Double-blinded Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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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:
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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
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
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The early incidence will be assessed between 1 and 2 hours after surgery
|
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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
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The late incidence will be assessed at 24 hours after surgery
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Secondary Outcome Measures
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
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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
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Po-Kai Wang, PhD, Buddhist Tzu Chi General Hospital
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- IRB108-27-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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