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

November 4, 2016 updated by: Dr Asish Subedi, B.P. Koirala Institute of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Koshi
      • Dharan, Koshi, Nepal, 56700
        • BP Koirala Institute of Health Sciences (BPKIHS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group LD: Lidocaine and Dexamethasone
lidocaine 1.5 mg/kg and dexamethasone (dexona) 8 mg iv prior to induction of anesthesia
Drug: LD: Lidocaine and dexamethasone
LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia
Other Names:
  • Xylocard, dexona
Active Comparator: Group L: Lidocaine
Group L: lidocaine 1.5 mg/kg iv prior to induction of anesthesia
Drug: L:Lidocaine
Intravenous lidocaine 1.5 mg/kg before induction of anesthesia
Other Names:
  • Xylocard
Active Comparator: D: Dexamethasone
Dexamethasone 8 mg iv prior to induction of anesthesia
Drug: D: Dexamethasone
D:intravenous dexamethasone 8 mg before induction of anesthesia
Other Names:
  • Dexona
Placebo Comparator: N: normal saline
N: normal saline (placebo): 2 ml
Drug: N: Normal saline (placebo)
Normal saline: 2ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 1 to 24 hr following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-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
From 1 to 24 hr following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.P. Koirala Institute of Health Sciences

Investigators

  • Principal Investigator: Asish Subedi, MD, BPKIHS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 2, 2013

First Submitted That Met QC Criteria

November 16, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 387/070/071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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