Comparison of Nebulized Ketamine With Nebulized Magnesium Sulfate for the Prevention of Postoperative Sore Throat
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine nebulizer, Mg sulfate nebulizer, Placebo.
- Who it may be relevant to
- Registry conditions: Postoperative Sore Throat. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Nebulized Ketamine With Nebulized Magnesium Sulfate for the Prevention of Postoperative Sore Throat in Adult Surgical Patients Undergoing General Anesthesia: Prospective Randomized Controlled Study
Overview
The aim of this study is to compare the efficacy of nebulized ketamine versus nebulized magnesium sulfate in reducing the incidence and severity of POST. * Primary outcome • To compare the incidence of POST method. * Secondary outcomes * Onset, Severity, and duration of POST at 0, 2, 4, 6, 12, 24 hours postoperative. * The hemodynamics recording (HR, BP, MBP, pre and post nebulization) * Adverse Effects (e.g., sedation, cough, nausea, vomiting, ….)
Detailed description
Post-operative sore throat (POST) is a common complication seen in patients after general anesthesia with endotracheal intubation although clinicians often regard it as a minor complication. The incidence of POST is estimated to be 21%-65% in different studies . The primary cause of POST is airway irritation and inflammation or trauma caused by an endotracheal tube; however, the airway may be extremely sensitive due to a preexisting comorbid condition. Regardless of its incidence and some preventive measures, POST is listed from the top as patients' most undesirable outcome in the postoperative period. POST is well recognized that reporting of sore throat is affected by the method of questioning that is whether the questions asked directly or indirectly .
The expression of POST constitutes a number of signs and symptoms. For example, sore throat is an ordinary expression of pharyngitis, which by itself can have a number of causes. It may also include a variety of symptoms including pain and discomfort, laryngitis, tracheitis, hoarseness, cough, or dysphagia. This leads to an increase in morbidity and causes further complications in patients .
Various pharmacological and nonpharmacological methods have been tried to decrease the incidence of POST with varying success rates. The pharmacological methods used for the prevention of POST are the use of inhalational, intravenous or topical agents that include beclomethasone gel, magnesium sulfate gargle, ketamine gargle, nebulized ketamine, magnesium sulfate nebulization, and lidocaine spray .
Nebulized medication administration is strongly recommended over intranasal delivery that is inhaled into the lungs and respiratory tract and is an important strategy for various respiratory problems and diseases. It reduces cough, temporary nasal discomfort, and vocal cord irritation. N-methyl-D-aspartate (NMDA) receptors had a crucial part in inflammation and nociception in the body. NMDA receptors exist in both peripheral nervous system (PNS) neurons and the central NS (CNS) .
Ketamine, an NMDA receptor antagonist, is commonly administered as a nebulizer to decline the severity and frequency of POST owing to its antinociceptive and anti-inflammatory properties .
Magnesium is also another NMDA receptor antagonist that plays a significant role in decreasing the incidence of POST. It is used as nebulizer; it is accessible and easily available in hospitals. The efficacy of preoperative nebulization of magnesium sulfate was assessed and found that the incidence and severity of POST were reduced at rest and on swallowing through 24 hours post extubation (8). Some studies showed that ketamine and magnesium can be used for attenuation of postoperative sore throat .
Interventions
- Drug Ketamine nebulizer
50 patients will receive preoperative nebulization with 50 mg ketamine in 5 ml normal saline. - Drug Mg sulfate nebulizer
50 patients will receive preoperative nebulization with 250 mg magnesium sulfate in 5 ml normal saline. - Drug Placebo
50 patients will receive preoperative nebulization with 5 ml normal saline.
Primary outcome measures
- To compare the incidence of Post operative sore throat method. [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Age from 18 to 65 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Elective surgery requiring GA with endotracheal intubation.
\- Exclusion Criteria:
- Surgery involves the oral cavity, nasopharynx, larynx, and neck regions.
- Surgery requires prone position.
- Surgery lasted more than 3 hours.
- History of preoperative sore throat, common cold.
- Anticipated difficult airway.
- Any known allergies to study drugs.
- Recent non-steroidal anti-inflammatory drugs use.
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07381036 · Soh-Med-25-12-7MS