Sore-throatPhase 4NCT05714540
Effect of Oropharyngeal Pack Soaked in Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgery
A Phase 4 study testing Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9% in people with Sore-throat and Nasopharyngeal Pack, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sore-throat, Nasopharyngeal Pack, Nasal Surgery
- What is being tested?
- Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study will include 90 adult patients of American Society of Anesthesiologists (ASA) physical status I and II, in the age group of 18 to 60 years of age, of either sex, who will be scheduled for elective nasal surgery (e.g. unilateral or bilateral functional endoscopic sinus surgery, sub mucousal resection, septorhinoplasty , polypectomy) under general anesthesia with endotracheal intubation, having a Mallampatti Grades of I and II and those who are willing to give informed consent.
Who cannot join
- History of recent respiratory tract infection or sore throat , anticipated difficult airway, known allergy to study drug, and preoperative use of analgesics such as non-steroidal anti-inflammatory drugs or opioids, Patients who required more than one attempt for tracheal intubation, or who will need tracheal intubation of <60 minutes or>300 minutes will be eliminated from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine beni Suef university
Banī Suwayf, 62511
Jehan Mohamed Mohamed, MD, 00201110269572, jehanmohamed1510@gmail.com
About this study
Official title: The Effect of Oropharyngeal Pack Soaked With Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgeries: Randomized Controlled Double Blind Study
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.
Read the detailed description
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).
- Being tested
- Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%
- Medical subject headings
- Pharyngitis, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%Drug
The Effect of Oropharyngeal Pack Soaked with Ketamine or Magnesium Sulphate on Post Operative Sore Throat after Nasal Surgeries
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 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 . Receives: Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9% |
| ketamine group | Active comparator | 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 Receives: Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9% |
| Magnesium group | Active comparator | The patients will receive 20 mg/kg magnesium sulfate soaked pharyngeal pack inserted in the posterior pharyngeal wall after induction of anesthesia and ETT Receives: Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative sore throat
Measured: 24 hours
Secondary outcomes (1)
nausea and vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start15 Feb 2023
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore-throatStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jehan Mohamed Mohamed Abdelghany, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714540
- Sponsor's protocol ID
- OPP in nasal surgery
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oropharyngeal Pack Soaked With Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgeries: Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT05714540
- Acronym / sponsor ID
- OPP in nasal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9%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 . |
| ketamine group | Active comparator | 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 |
| Magnesium group | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will include 90 adult patients of American Society of Anesthesiologists (ASA) physical status I and II, in the age group of 18 to 60 years of age, of either sex, who will be scheduled for elective nasal surgery (e.g. unilateral or bilateral functional endoscopic sinus surgery, sub mucousal resection, septorhinoplasty , polypectomy) under general anesthesia with endotracheal intubation, having a Mallampatti Grades of I and II and those who are willing to give informed consent.
Key exclusion criteria (1 listed)
- History of recent respiratory tract infection or sore throat , anticipated difficult airway, known allergy to study drug, and preoperative use of analgesics such as non-steroidal anti-inflammatory drugs or opioids, Patients who required more than one attempt for tracheal intubation, or who will need tracheal intubation of <60 minutes or>300 minutes will be eliminated from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Control group, Magnesium group, ketamine group |
Primary outcome
post operative sore throat
Time frame: 24 hours
1 secondary outcome
nausea and vomiting
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine Hydrochloride ,Magnesium sulphate and saline 0.9% in people with Sore-throat and Nasopharyngeal Pack, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jehan Mohamed Mohamed, MD (00201110269572, jehanmohamed1510@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative sore throat (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.