Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Intravenous Dynastat on Postoperative Sore Throat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915561
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Po-Kai Wang, Buddhist Tzu Chi General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sore Throat Postoperative Complications Drug: Parecoxib Injectable Product Drug: Normal saline Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a two-arm, individually randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The randomization list will be generated using computer sequence number, and patient allocation ratio will be 1:1. Written allocation group will be sealed in individual opaque envelopes marked externally only with study identification numbers. An anesthetic assistant not participating in the study prepared the drug solution after breaking the codes
Primary Purpose: Prevention
Official Title: Effect of Intravenous Dynastat on Postoperative Sore Throat: A Randomized Double-blinded Controlled Trial
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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
Drug: Parecoxib Injectable Product
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 Name: Dynastat

Placebo Comparator: Placebo
This group will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice
Drug: Normal saline
Placebo group (0.9% saline, group S) will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915561


Contacts
Layout table for location contacts
Contact: Po-Kai Wang, PhD +886-3-856-1825 ext 16238 pk8511034@yahoo.com.tw

Locations
Layout table for location information
Taiwan
Po-Kai Wang Recruiting
Hualien City, Hualien, Taiwan, 97002
Contact: Po-Kai Wang, PD    +886-3-856-1825 ext 16238    pk8511034@yahoo.com.tw   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Po-Kai Wang, PhD Buddhist Tzu Chi General Hospital
Publications of Results:

Layout table for additonal information
Responsible Party: Po-Kai Wang, Head of Pain Management, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03915561    
Other Study ID Numbers: IRB108-27-A
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Po-Kai Wang, Buddhist Tzu Chi General Hospital:
postoperative sore throat
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Postoperative Complications
Pathologic Processes
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Parecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents