NCT05343429

Brief Summary

Post-operative sore throat (POST) following General Anesthesia with endotracheal is a common symptom and drains resources. The researchers will compare preoperative gargling of Asprine and Benzydamine HCL to study comparative effects on intensity and duration of POST. Data collected as such will be analyzed to reach at a conclusion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

April 18, 2022

Last Update Submit

May 6, 2022

Conditions

Sore Throat

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative sore throat (POST) in both groups

    Rate (incidence) of Postoperative sore throat (POST) in both groups will be calculated and compared with each other.

    Six hours

Secondary Outcomes (2)

  • Duration of Postoperative sore throat (POST) in both groups

    Six hours post-operative period

  • Severity of Postoperative sore throat (POST) in both groups

    Six hours post-operative period

Study Arms (2)

Benzydamine hydrochloride (BN)

ACTIVE COMPARATOR

15 ml of 0.15 % Benzydamine hydrochloride (BN) to dissolved in 15 ml plain water in a sterile container

Drug: Benzydamine hydrochloride

Aspirin (Ap)

ACTIVE COMPARATOR

600 mg Aspirin tablets dissolved in 30 ml of plain water

Drug: Aspirin

Interventions

Benzydamine hydrochlorideDRUG

In BN group,15 ml of 0.15 % Benzydamine hydrochloride (BN) will be dissolved in 15 ml plain water in a sterile container and given to participants before anesthesia for surgery

Also known as: BENZIRIN oral rinse 240ml by Adamjee Pharmaceuticals (Pvt.) Ltd.
Benzydamine hydrochloride (BN)
AspirinDRUG

In group AP, Aspirin (AP) 600 mg Aspirin tablets dissolved in 30 ml of plain water in a sterile container will be given to participants for gargling before anesthesia for surgery

Also known as: Tablets. Disprin 300 mg (soluble) by by Reckitt Benckiser (Pvt.) Ltd.
Aspirin (Ap)

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of American Society of Anesthesiologists Class 1 and 2 (ASA 1 and 2) scheduled for gynecological surgery under General Anesthesia with Intra tracheal Intubation and expected to finish in less than three hours will be included in the study.
  • Patients of 18- 60 years of age will be included.
  • Patients of Mallampati class 1 and 2 will be selected, as these have easy intubation predicted.
  • Patients qualifying for easy intubation (prediction based on mouth opening, neck mobility etc.) will be selected.
  • Patients in supine position only.

You may not qualify if:

  • Patients who are unable to gargle properly.
  • Patients who require more than 2 attempts at intubation.
  • Patients of Cormack-Lehane Grade 3 and 4 on direct laryngoscopy (multiple intubating attempts may be required).
  • Patients requiring oral cavity instrumentation e.g. N/G tube placement, oral or laryngeal surgeries including tonsillectomies
  • Patients whose head are frequently turned \> 90 degrees with ETT placed in.
  • Patients whose surgery is prolonged beyond 3 hour.
  • Patients who require postoperative mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehman Medical Institute

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

Related Publications (12)

  • Chandler M. Tracheal intubation and sore throat: a mechanical explanation. Anaesthesia. 2002 Feb;57(2):155-61. doi: 10.1046/j.1365-2044.2002.02329.x.

    PMID: 11871952BACKGROUND

  • Piriyapatsom A, Dej-Arkom S, Chinachoti T, Rakkarnngan J, Srishewachart P. Postoperative sore throat: incidence, risk factors, and outcome. J Med Assoc Thai. 2013 Aug;96(8):936-42.

    PMID: 23991600RESULT

  • 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: 27158989RESULT

  • Calder A, Hegarty M, Erb TO, von Ungern-Sternberg BS. Predictors of postoperative sore throat in intubated children. Paediatr Anaesth. 2012 Mar;22(3):239-43. doi: 10.1111/j.1460-9592.2011.03727.x. Epub 2011 Nov 8.

    PMID: 22066487RESULT

  • Patki A. Laryngeal mask airway vs the endotracheal tube in paediatric airway management: A meta-analysis of prospective randomised controlled trials. Indian J Anaesth. 2011 Sep;55(5):537-41. doi: 10.4103/0019-5049.89900.

    PMID: 22174478RESULT

  • Mostafa RH, Saleh AN, Hussein MM. A comparative study of three nebulized medications for the prevention of postoperative sore throat in the pediatric population. Open Anesthesia J. 2018;12(1):85-93.

    RESULT

  • Chen CY, Kuo CJ, Lee YW, Lam F, Tam KW. Benzydamine hydrochloride on postoperative sore throat: a meta-analysis of randomized controlled trials. Can J Anaesth. 2014 Mar;61(3):220-8. doi: 10.1007/s12630-013-0080-y. Epub 2013 Nov 22.

    PMID: 24263969RESULT

  • Agarwal A, Nath SS, Goswami D, Gupta D, Dhiraaj S, Singh PK. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study. Anesth Analg. 2006 Oct;103(4):1001-3. doi: 10.1213/01.ane.0000231637.28427.00.

    PMID: 17000820RESULT

  • Mayhood J, Cress K. Effectiveness of ketamine gargle in reducing postoperative sore throat in patients undergoing airway instrumentation: a systematic review. JBI Database System Rev Implement Rep. 2015 Sep;13(9):244-78. doi: 10.11124/jbisrir-2015-2045.

    PMID: 26470672RESULT

  • 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: 26171894RESULT

  • Kuriyama A, Maeda H. Preoperative intravenous dexamethasone prevents tracheal intubation-related sore throat in adult surgical patients: a systematic review and meta-analysis. Can J Anaesth. 2019 May;66(5):562-575. doi: 10.1007/s12630-018-01288-2. Epub 2019 Jan 7.

    PMID: 30617677RESULT

  • Yhim HB, Yoon SH, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 4;20(1):77. doi: 10.1186/s12871-020-00995-y.

    PMID: 32247315RESULT

MeSH Terms

Conditions

Pharyngitis

Interventions

BenzydamineLong-Term Synaptic DepressionAspirin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

IndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mohammad Shafiq, FCPS

    Rehman Medical institute, Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Shafiq, FCPS

CONTACT

+92-91-5838000mohammad.shafiq@rmi.edu.pk

Rahman U Jan, MCPS

CONTACT

+92-3339749567janrahman21@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
A pharmacist not part of the study will prepare two solutions, one of Benzydamine hydrochloride (BH) 0.15 % 15 ml diluted to 30 ml by adding plain water and another of Aspirin (AS) 600 mg dissolved in 30 ml plain water. The randomized patients will gargle with either BH and AS solution five minutes before conduct of General Anesthesia. The unique identification will be known only to principal investigator.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment The study design is prospective double-blinded randomized controlled parallel trial with allocation ratio of 1:1.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiologist

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 25, 2022

Study Start

April 1, 2022

Primary Completion

October 30, 2022

Study Completion

December 31, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Yes Data including clinical and demographic characteristics, not affecting patient's confidentiality, will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
April, 2022 to April, 2025
Access Criteria
IPD will be shared on inter institutional request basis.

Locations

PA(1)