Comparing Efficacy Preoperative Nebulized: Ketamine , Mgspo4 ,and Lidocaine In Attenuating Endotracheal Sore Throat

NCT03729973 | Completed Phase 3 DMC

• 1 other identifier: 4915
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most common complications after endotracheal intubation is sore throat Lidocaine jelly or spray, preoperative gargles with licorice or ketamine or I.V steroids used for prophylaxis against POST are expensive ,and having much more side effects,but nebulized lidocaine is easily found with decreasing cost ,easily administered ,acts immediately with short duration ,minimal side effects ,and no term residual side effects. Nebulized ketamine was found to have a protective effect on allergen-induced airway inflammatory injury , high airway reactivity ,and decreasing postoperative sore throat (POST) incidence . Magnesium sulfate is similar to ketamine in blocking the N-methyl-D-aspartate receptors.

Conditions

Sore Throat

Outcome Measures

Primary Outcomes (1)

• 4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. .

  The intensity of sore throat will be recorded at 2,4,8,12,24 hours postoperatively on 4 point scale (0-3): 0= no sore throat 1. mild sore throat (complaint of sore throat on asking). 2. moderate sore throat (change in voice or hoarseness associated with throat pain). 3. sever sore throat (change in voice or hoarseness associated with throat pain).

  2,4,8,12,24 hours

Study Arms (4)

Group (K)

ACTIVE COMPARATOR

Group (K) (n=25): patients nebulized ketamine 50 mg(milgram) (1ml) plus 4ml normal saline.So total volume (5ml). In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized 1ml ketamine (Ketalar 50mg/VI Solution for Injection) by compressor nebulizing for 15 minutes.

Drug: Ketamine

Group (M)

ACTIVE COMPARATOR

Group M(n=25) : patients nebulized isotonic magnesium sulfate 250mg (3ml)( 50% Magnesium Sulfate Injection)plus 1ml normal saline. In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized by compressor nebulizing for 15 minutes.

Drug: Magnesium Sulfate

Group (L)

ACTIVE COMPARATOR

Group (L) (n=25): patients nebulized lidocaine 2% 100mg .So total volume (5ml). In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized by compressor nebulizing for 15 minutes.

Drug: Lidocaine

Group (C)

ACTIVE COMPARATOR

Group (C) (n=25): patients nebulized normal saline(0.9%). 5ml .In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized by compressor nebulizing for 15 minutes.

Drug: Normal saline

Interventions

Ketamine DRUG

Patients nebulized ketamine by compressor nebulizing for 15 minutes.

Also known as: (Ketalar, 50 Mg/mL Injectable Solution)

Group (K)

Magnesium Sulfate DRUG

Patients nebulized magnesium sulfate 250mg (3ml)plus 2ml normal saline by compressor nebulizing for 15 minutes.

Also known as: (Magnesium Sulfate 500 /ML)

Group (M)

Lidocaine DRUG

In preparation room an I.V line was secured ,and standard monitoring was connected to patient. Patients nebulized lidocaine 5ml by compressor nebulizing for 15 minutes.

Also known as: (Xylocaine 2 % Injectable Solution)

Group (L)

Normal saline DRUG

In preparation room an I.V line was secured ,and standard monitoring was connected to patient. Patients nebulized by compressor nebulizing 5ml normal saline for 15 minutes.

Also known as: (Normal Saline 0.9% Infusion Solution)

Group (C)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• Age (21-45) years old.
• American Society of Anesthesiologists (ASA) I / II
• elective surgery of approximately 2-3h duration needing endotracheal intubation
• Patient With BMI(Body Mass Index)(25-30)

You may not qualify if:

• Patient refusal.
• Altered mental status.
• History of allergy to drugs in the study
• Patients with history of pervious sore throat
• using steroids or NSAIDs,with asthma
• neuromuscular disease
• , Mallampati grade\>2, with \>2 attempts of intubations,
• underlying neck ,and laparoscopic surgeries,
• pregnant women.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitsals

Zagazig, 055, Egypt

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Ketamine; Magnesium Sulfate; Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alshaimaa Kamel, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectuerer

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: November 5, 2018
• Study Start: November 15, 2018
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)