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

Primary Purpose

Postoperative Sore Throat, Cough, Hoarseness

Status
Completed
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
LD: Lidocaine and dexamethasone
L:Lidocaine
D: Dexamethasone
N: Normal saline (placebo)
Sponsored by
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Sore Throat, Cough, Hoarseness focused on measuring Lidocaine, Dexamethasone, Postoperative sore throat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BP Koirala Institute of Health Sciences (BPKIHS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group LD: Lidocaine and Dexamethasone

Group L: Lidocaine

D: Dexamethasone

N: normal saline

Arm Description

lidocaine 1.5 mg/kg and dexamethasone (dexona) 8 mg iv prior to induction of anesthesia

Group L: lidocaine 1.5 mg/kg iv prior to induction of anesthesia

Dexamethasone 8 mg iv prior to induction of anesthesia

N: normal saline (placebo): 2 ml

Outcomes

Primary Outcome Measures

Assessment of postoperative sore throat at rest and on swallowing.
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 Outcome Measures

-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.
-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

Full Information

First Posted
November 2, 2013
Last Updated
November 4, 2016
Sponsor
B.P. Koirala Institute of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01990781
Brief Title
Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.
Official Title
Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat, Cough, Hoarseness
Keywords
Lidocaine, Dexamethasone, Postoperative sore throat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group LD: Lidocaine and Dexamethasone
Arm Type
Experimental
Arm Description
lidocaine 1.5 mg/kg and dexamethasone (dexona) 8 mg iv prior to induction of anesthesia
Arm Title
Group L: Lidocaine
Arm Type
Active Comparator
Arm Description
Group L: lidocaine 1.5 mg/kg iv prior to induction of anesthesia
Arm Title
D: Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 8 mg iv prior to induction of anesthesia
Arm Title
N: normal saline
Arm Type
Placebo Comparator
Arm Description
N: normal saline (placebo): 2 ml
Intervention Type
Drug
Intervention Name(s)
LD: Lidocaine and dexamethasone
Other Intervention Name(s)
Xylocard, dexona
Intervention Description
LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
L:Lidocaine
Other Intervention Name(s)
Xylocard
Intervention Description
Intravenous lidocaine 1.5 mg/kg before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
D: Dexamethasone
Other Intervention Name(s)
Dexona
Intervention Description
D:intravenous dexamethasone 8 mg before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
N: Normal saline (placebo)
Intervention Description
Normal saline: 2ml
Primary Outcome Measure Information:
Title
Assessment of postoperative sore throat at rest and on swallowing.
Description
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
Time Frame
From 1 to 24 hr following surgery
Secondary Outcome Measure Information:
Title
-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.
Description
-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
Time Frame
From 1 to 24 hr following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asish Subedi, MD
Organizational Affiliation
BPKIHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
BP Koirala Institute of Health Sciences (BPKIHS)
City
Dharan
State/Province
Koshi
ZIP/Postal Code
56700
Country
Nepal

12. IPD Sharing Statement

Citations:
PubMed Identifier
30320641
Citation
Subedi A, Tripathi M, Pokharel K, Khatiwada S. Effect of Intravenous Lidocaine, Dexamethasone, and Their Combination on Postoperative Sore Throat: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):220-225. doi: 10.1213/ANE.0000000000003842.
Results Reference
derived

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

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