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Completed

NCT Number: NCT01990781

Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.

Post operative sore throat (POST) following tracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and dexamethasone has been used independently for this purpose. However, there is no study assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine dexamethasone combination on the incidence and severity of POST.

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Key information

Conditions

Postoperative Sore Throat, Cough, Hoarseness Cough Hoarseness Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Voice Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, 56700, Nepal

About this study

Sore throat and hoarseness following tracheal intubation are common postoperative problems causing dissatisfaction and discomfort to the patients. Their incidence varies from 30%-70%.

Both non pharmacological and pharmacological measures have been tried to minimize the incidence and severity of POST with variable success rate. Prophylactic use lidocaine and steroids have been used independently for this purpose. Dexamethasone as an adjuvant to lidocaine has shown to improve the quality of analgesia. However, there is no study assessing the combine effects of lidocaine and dexamethasone for POST.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of American Society of Anesthesiologist(ASA) physical status 1 & 2 requiring general anesthesia with endotracheal intubation.
  • Duration of surgery more than 90 min

Exclusion criteria

  • Those with preexisting hoarseness or sorethroat
  • Smoker
  • Vocal performer by occupation
  • Recent or recurrent respiratory tract infection
  • Risk factors for postoperative aspiration
  • Obesity
  • Pregnancy
  • Receiving analgesics, corticosteroids and calcium channel blockers
  • Contraindication to corticosteroid medications
  • Anticipated difficult intubation
  • Mallampati grade > 2
  • Difficult mask ventilation requiring oral or nasal airway
  • Cormack and Lehman grade III and IV on laryngoscopy
  • More than one intubation attempt
  • Those requiring orogastric or nasogastric tubes

Treatment and study plan

LD: Lidocaine and dexamethasone

Drug

LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia

Other names: Xylocard, dexona

L:Lidocaine

Drug

Intravenous lidocaine 1.5 mg/kg before induction of anesthesia

Other names: Xylocard

D: Dexamethasone

Drug

D:intravenous dexamethasone 8 mg before induction of anesthesia

Other names: Dexona

N: Normal saline (placebo)

Drug

Normal saline: 2ml

Primary outcomes

  1. Assessment of postoperative sore throat at rest and on swallowing.

    Time frame: From 1 to 24 hr following surgery

    Incidence of postoperative sore throat. Assessment of severity of postoperative sorethroat using scoring system, 0-No sore throat at any time since the operation,1- Minimal sore throat,2- Moderate sore throat,3- Severe sore throat

Secondary outcomes

  1. -Assessment of post operative cough. Assessment of post operative cough using scoring system,0- No cough,1- Minimal cough,2- Moderate cough,3- Severe cough.

    Time frame: From 1 to 24 hr following surgery

    -Assessment of postoperative hoarseness. Assessment of postoperative hoarseness using scoring system,0- No evidence of hoarseness at any time since the operation,1-No evidence of hoarseness at the time of interview,2-Hoarseness at the time of interview noted by patient only, 3- Hoarseness that is easily noted at the time of interview

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Official study title

Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 21, 2013
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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