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

NCT01990781 | Completed Phase 4

• 1 other identifier: 387/070/071
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Sore Throat, Cough, Hoarseness

Keywords

Lidocaine, Dexamethasone, Postoperative sore throat

Outcome Measures

Primary Outcomes (1)

• 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

  From 1 to 24 hr following surgery

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.

  From 1 to 24 hr following surgery

Study Arms (4)

Group LD: Lidocaine and Dexamethasone

EXPERIMENTAL

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

Drug: LD: Lidocaine and dexamethasone

Group L: Lidocaine

ACTIVE COMPARATOR

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

Drug: L:Lidocaine

D: Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 8 mg iv prior to induction of anesthesia

Drug: D: Dexamethasone

N: normal saline

PLACEBO COMPARATOR

N: normal saline (placebo): 2 ml

Drug: N: Normal saline (placebo)

Interventions

LD: Lidocaine and dexamethasone DRUG

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

Also known as: Xylocard, dexona

Group LD: Lidocaine and Dexamethasone

L:Lidocaine DRUG

Intravenous lidocaine 1.5 mg/kg before induction of anesthesia

Also known as: Xylocard

Group L: Lidocaine

D: Dexamethasone DRUG

D:intravenous dexamethasone 8 mg before induction of anesthesia

Also known as: Dexona

D: Dexamethasone

N: Normal saline (placebo) DRUG

Normal saline: 2ml

N: normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, 56700, Nepal

Location

Related Publications (1)

• 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.

  PMID: 30320641 DERIVED

MeSH Terms

Conditions

Cough; Hoarseness

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Asish Subedi, MD

  BPKIHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology, BPKIHS

Study Record Dates

• First Submitted: November 2, 2013
• First Posted: November 21, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

NE (1)