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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by B.P. Koirala Institute of Health Sciences
Sponsor:
Information provided by (Responsible Party):
Dr Asish Subedi, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier:
NCT01990781
First received: November 2, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Postoperative Sore Throat, Cough, Hoarseness
Drug: LD: Lidocaine and dexamethasone
Drug: L:Lidocaine
Drug: D: Dexamethasone
Drug: N: Normal saline (placebo)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by B.P. Koirala Institute of Health Sciences:

Primary Outcome Measures:
  • Assessment of postoperative sore throat at rest and on swallowing. [ Time Frame: From 1 to 24 hr following surgery ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: From 1 to 24 hr following surgery ] [ Designated as safety issue: Yes ]
    -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


Estimated Enrollment: 168
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Dexona
Placebo Comparator: N: normal saline
N: normal saline (placebo): 2 ml
Drug: N: Normal saline (placebo)
Normal saline: 2ml

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990781

Contacts
Contact: Asish Subedi, MD 977-25-525555 ext 2013 subediasish@yahoo.com

Locations
Nepal
BP Koirala Institute of Health Sciences (BPKIHS) Recruiting
Dharan, Koshi, Nepal, 56700
Contact: Asish Subedi, MD    977-25-525555 ext 2013    subediasish@yahoo.com   
Principal Investigator: Asish Subedi, MD         
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Investigators
Principal Investigator: Asish Subedi, MD BPKIHS
  More Information

No publications provided

Responsible Party: Dr Asish Subedi, Associate Professor, Department of Anesthesiology, BPKIHS, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT01990781     History of Changes
Other Study ID Numbers: 387/070/071
Study First Received: November 2, 2013
Last Updated: July 21, 2014
Health Authority: Nepal: Health Research Council

Keywords provided by B.P. Koirala Institute of Health Sciences:
Lidocaine, Dexamethasone, Postoperative sore throat

Additional relevant MeSH terms:
Pharyngitis
Cough
Hoarseness
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Voice Disorders
Laryngeal Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lidocaine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 28, 2014