Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729973
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Alshaimaa Abdel Fattah Kamel, Zagazig University

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.


Condition or disease Intervention/treatment Phase
Sore Throat Drug: Ketamine Drug: Magnesium Sulfate Drug: Lidocaine Drug: Normal saline Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparing The Efficacy Of Preoperative Nebulized: Ketamine, Magnesium Sulfate, and Lidocaine In Attenuating Postoperative Sore Throat After Endotracheal Intubation
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Active Comparator: Group (K)

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
Patients nebulized ketamine by compressor nebulizing for 15 minutes.
Other Name: (Ketalar, 50 Mg/mL Injectable Solution)

Active Comparator: Group (M)

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
Patients nebulized magnesium sulfate 250mg (3ml)plus 2ml normal saline by compressor nebulizing for 15 minutes.
Other Name: (Magnesium Sulfate 500 /ML)

Active Comparator: Group (L)

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

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.

Other Name: (Xylocaine 2 % Injectable Solution)

Active Comparator: Group (C)

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

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.

Other Name: (Normal Saline 0.9% Infusion Solution)




Primary Outcome Measures :
  1. 4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. . [ Time Frame: 2,4,8,12,24 hours ]

    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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729973


Locations
Layout table for location information
Egypt
Zagazig University Hospitsals
Zagazig, Egypt, 055
Sponsors and Collaborators
Zagazig University
Investigators
Layout table for investigator information
Principal Investigator: Alshaimaa Kamel, MD Zagazig University
Layout table for additonal information
Responsible Party: Alshaimaa Abdel Fattah Kamel, lectuerer, Zagazig University
ClinicalTrials.gov Identifier: NCT03729973    
Other Study ID Numbers: 4915
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lidocaine
Magnesium Sulfate
Ketamine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Anticonvulsants
Calcium Channel Blockers