Effect of Intravenous Dynastat on Postoperative Sore Throat

NCT03915561 | Unknown Phase 2 DMC

• 1 other identifier: IRB108-27-A
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Sore Throat; Postoperative Complications

Keywords

postoperative sore throat

Outcome Measures

Primary Outcomes (2)

• The early incidence of POST

  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

  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 Outcomes (2)

• The early severity of POST

  The early severity of POST will be assessed between 1 and 2 hours after surgery

• The late severity of POST

  The late severity will be assessed at 24 hours after surgery

Study Arms (2)

Study group

ACTIVE COMPARATOR

This group will be received intravenous injection with 10ml transparent mixture solution with 40mg Dynastat and 0.9% saline twice

Drug: Parecoxib Injectable Product

Placebo

PLACEBO COMPARATOR

This group will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice

Drug: Normal saline

Interventions

Parecoxib Injectable Product DRUG

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.

Also known as: Dynastat

Study group

Normal saline DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Po-Kai Wang

Hualien City, Hualien, 97002, Taiwan

RECRUITING

Related Publications (8)

• 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.

  PMID: 26171894 RESULT

• 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.

  PMID: 15777293 RESULT

• 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.

  PMID: 10995141 RESULT

• 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.

  PMID: 27158989 RESULT

• Cheer SM, Goa KL. Parecoxib (parecoxib sodium). Drugs. 2001;61(8):1133-41; discussion 1142-3. doi: 10.2165/00003495-200161080-00010.

  PMID: 11465874 RESULT

• 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.

  PMID: 15232360 RESULT

• 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.

  PMID: 17577465 RESULT

• 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.

  PMID: 19095866 RESULT

MeSH Terms

Conditions

Pharyngitis; Postoperative Complications

Interventions

parecoxib; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Po-Kai Wang, PhD

  Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Kai Wang, PhD

CONTACT

+886-3-856-1825; pk8511034@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pain Management

Model Details: a two-arm, individually randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 16, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: November 30, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)