A Phase 4 interventional study of Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9% in Sore-throat, Nasopharyngeal Pack and Nasal Surgery, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Beni-Suef University · Phase 4, Interventional, and Prevention
The aim of this study is to compare the effect of ketamine or magnesium sulphate soaked throat pack on the incidence and severity of post operative sore throat as a primary outcome, post operative nausea and vomiting as a secondary outcome following elective nasal surgery under general anesthesia.
Postoperative sore throat (POST) is defined as pain, discomfort, or irritation in the throat after general anesthesia and tracheal intubation that worsens with swallowing. Etiological factors playing a significant role in this anesthetic complication are: Size of the endotracheal tube, design and pressure of cuff, the use of nasogastric tubes, lubricants, muscle relaxants, duration of surgery, surgery in and around the oral cavity, trauma arising from laryngoscopy, and use of pharyngeal packs. Pharyngeal packs are commonly used during nasal surgeries to prevent aspiration, tracheal contamination and passage of blood into the stomach. They are disputed to increase the incidence of postoperative sore throat (POST), but surgery in and around the oral cavity necessitates them to soak blood and debris that result as consequence of surgery and decrease post operative nausea and vomiting. Nausea and vomiting are important postoperative complications in all surgical settings and more in nasal surgery due to the presence of blood in the stomach, pain and inflammation of the uvula and throat, and the occasional use of opioids for pain control are all contributing factors. Many interventions can be used to decrease incidence of POST. These include using smaller endotracheal tube size including video laryngoscopy in intubation process, limiting endotracheal cuff pressure and perioperative use of steroids (intravenous, topical or inhaled). Also pharyngeal packs soaked with agents with analgesic effect can be used to decrease post operative sore throat, nausea and vomiting. N methyl D aspartate (NMDA) receptors are present in the central nervous system and also in the peripheral nervous system . These receptors contribute in inflammatory pain. Ketamine and Magnesium sulphate are NMDA antagonist with antinociceptive and anti-inflammatory effect, which may be a possible mechanism in prevention of postoperative sore throat (POST).
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's planned enrollment of 90 is below the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
Compared within Postoperative Nausea and Vomiting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients will receive 20 ml 0.9% saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and endotracheal intubation .
Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
The patients will receive ketamine soaked 50 mg ketamine in 20 ml normal saline soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT insertion
Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
The patients will receive 20 mg/kg magnesium sulfate soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT
Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
The Effect of Oropharyngeal Pack Soaked with Ketamine or Magnesium Sulphate on Post Operative Sore Throat after Nasal Surgeries
post operative sore throat
Time frame: 24 hours
nausea and vomiting
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Aug 2023, 6 months after the start.
Of 67 non-industry phase 4 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 6 months is below that.
Counting every sponsor, half of 67 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
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Postoperative Nausea and Vomiting →