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

NCT ID: NCT01990781

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Postoperative Sore Throat, Cough, Hoarseness

Keywords

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Lidocaine, Dexamethasone, Postoperative sore throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group LD: Lidocaine and Dexamethasone

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

Group Type EXPERIMENTAL

LD: Lidocaine and dexamethasone

Intervention Type DRUG

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

Group L: Lidocaine

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

Group Type ACTIVE_COMPARATOR

L:Lidocaine

Intervention Type DRUG

Intravenous lidocaine 1.5 mg/kg before induction of anesthesia

D: Dexamethasone

Dexamethasone 8 mg iv prior to induction of anesthesia

Group Type ACTIVE_COMPARATOR

D: Dexamethasone

Intervention Type DRUG

D:intravenous dexamethasone 8 mg before induction of anesthesia

N: normal saline

N: normal saline (placebo): 2 ml

Group Type PLACEBO_COMPARATOR

N: Normal saline (placebo)

Intervention Type DRUG

Normal saline: 2ml

Interventions

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LD: Lidocaine and dexamethasone

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

Intervention Type DRUG

L:Lidocaine

Intravenous lidocaine 1.5 mg/kg before induction of anesthesia

Intervention Type DRUG

D: Dexamethasone

D:intravenous dexamethasone 8 mg before induction of anesthesia

Intervention Type DRUG

N: Normal saline (placebo)

Normal saline: 2ml

Intervention Type DRUG

Other Intervention Names

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Xylocard, dexona Xylocard Dexona

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr Asish Subedi

Associate Professor, Department of Anesthesiology, BPKIHS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asish Subedi, MD

Role: PRINCIPAL_INVESTIGATOR

BPKIHS

Locations

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BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type DERIVED
PMID: 30320641 (View on PubMed)

Other Identifiers

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387/070/071

Identifier Type: -

Identifier Source: org_study_id