Postoperative Sore ThroatNCT06368843
the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat
An observational study of Postoperative Sore Throat, run by Al-Azhar University at 1 site in Iraq.
Trial summary
Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- Gargle with ketamine
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 25 Apr 2024to 20 Sep 2024
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The patients undergoing appendectomy or cholecystectomy under general anesthesia with endotracheal intubation in Al-Nasiriyah Teaching Hospital.
Who may be able to join
- Adult patients from both sex and aged between 18 and 45 years.
- All participants were scheduled for elective laparoscopic appendectomy or cholecystectomy under general anesthesia.
- Classified as ASA (American Society of Anesthesiologists) I or II.
- Intubation duration is less than 90 minutes.
Who cannot join
- Patients classified as ASA III or higher.
- Patients exhibiting symptoms of sore throat prior to entering the operating room, or presenting with any respiratory illness or signs of respiratory infection.
- Patients who smoke.
- Patients with a history of allergy to drugs used in this study.
- Patients who are addicted to steroid drugs (inhaled or oral).
- Patients with predicted difficult airway and intubation, indicated by a Mallampati score of II or higher.
- Obese patients with a BMI exceeding 35.
- Patients with neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Ketamine Gargling on Post Intubation Sore Throat: A Randomized Controlled Trial.
Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction.
Read the detailed description
Patients have ranked POST as the eighth most adverse effect during the postoperative period. Various methods, both non-pharmacological and pharmacological, have been explored to mitigate POST with varying degrees of success. Non-pharmacological approaches include using smaller-sized endotracheal tubes, lubricating the tube with water-soluble jelly, employing careful airway instrumentation, ensuring intubation after full relaxation, employing gentle oropharyngeal suctioning, minimizing intracuff pressure, and deflating the tracheal tube cuff completely before extubation, all of which have been reported to reduce the incidence of POST.
- Conditions
- Postoperative Sore Throat
- Being tested
- Gargle with ketamine
- Keywords
- ketamine gargling, Post-operative sore throat, endotracheal tube complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gargle with ketamineDrug
Also called Placebo
The patients asked to gargling with ketamine solution in the preoperative waiting area after explain the whole procedure and the goals of the study.
| Study group | Role | What they receive |
|---|---|---|
| the 1st group (K group) | the 1st group (K group) consisted of 46 patients who were instructed to gargle with a ketamine solution Receives: Drug: Gargle with ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore throat
A sore throat is characterized by pain, scratchiness, or irritation in the throat, typically aggravated by swallowing.
Measured: 2, 6, 12, and 24 hrs. postoperatively
Secondary outcomes (2)
Cough
Coughing and bucking while intubated on emergence from general anesthesia unfortunately occurs in approximately 40% of patients
Measured: 2, 6, 12, and 24 hrs. postoperatively
Hoarseness of voice
Hoarseness of voice is a common complication after tracheal intubation and may be very limiting for a patient after anesthesia.
Measured: 2, 6, 12, and 24 hrs. postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368843
- Sponsor's protocol ID
- Ketamine for POST
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share any data about the participants with other researchers; but we will share the results after doing our analysis.
Publications
Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.
PubMed 7880666Loeser EA, Bennett GM, Orr DL, Stanley TH. Reduction of postoperative sore throat with new endotracheal tube cuffs. Anesthesiology. 1980 Mar;52(3):257-9. doi: 10.1097/00000542-198003000-00011. No abstract available.
PubMed 7369513Al-Qahtani AS, Messahel FM. Quality improvement in anesthetic practice--incidence of sore throat after using small tracheal tube. Middle East J Anaesthesiol. 2005 Feb;18(1):179-83.
PubMed 15830773
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Ketamine Gargling on Post Intubation Sore Throat: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06368843
- Acronym / sponsor ID
- Ketamine for POST
- Conditions
- Postoperative Sore Throat
- Keywords
- ketamine gargling, Post-operative sore throat, endotracheal tube complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 16 Apr 2024 (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.
Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction.
Detailed description
Patients have ranked POST as the eighth most adverse effect during the postoperative period. Various methods, both non-pharmacological and pharmacological, have been explored to mitigate POST with varying degrees of success. Non-pharmacological approaches include using smaller-sized endotracheal tubes, lubricating the tube with water-soluble jelly, employing careful airway instrumentation, ensuring intubation after full relaxation, employing gentle oropharyngeal suctioning, minimizing intracuff pressure, and deflating the tracheal tube cuff completely before extubation, all of which have been reported to reduce the incidence of POST.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the 1st group (K group) | – | Drug: Gargle with ketaminethe 1st group (K group) consisted of 46 patients who were instructed to gargle with a ketamine solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The patients undergoing appendectomy or cholecystectomy under general anesthesia with endotracheal intubation in Al-Nasiriyah Teaching Hospital.
Key inclusion criteria (4 listed)
- Adult patients from both sex and aged between 18 and 45 years.
- All participants were scheduled for elective laparoscopic appendectomy or cholecystectomy under general anesthesia.
- Classified as ASA (American Society of Anesthesiologists) I or II.
- Intubation duration is less than 90 minutes.
Key exclusion criteria (8 listed)
- Patients classified as ASA III or higher.
- Patients exhibiting symptoms of sore throat prior to entering the operating room, or presenting with any respiratory illness or signs of respiratory infection.
- Patients who smoke.
- Patients with a history of allergy to drugs used in this study.
- Patients who are addicted to steroid drugs (inhaled or oral).
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 |
|---|---|---|
| Gargle with ketamineAlso: PlaceboThe patients asked to gargling with ketamine solution in the preoperative waiting area after explain the whole procedure and the goals of the study. | Drug | the 1st group (K group) |
Primary outcome
Sore throat
Time frame: 2, 6, 12, and 24 hrs. postoperatively
A sore throat is characterized by pain, scratchiness, or irritation in the throat, typically aggravated by swallowing.
2 secondary outcomes
Cough
Time frame: 2, 6, 12, and 24 hrs. postoperatively
Hoarseness of voice
Time frame: 2, 6, 12, and 24 hrs. postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 7880666Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.
- Background: PubMed 7369513Loeser EA, Bennett GM, Orr DL, Stanley TH. Reduction of postoperative sore throat with new endotracheal tube cuffs. Anesthesiology. 1980 Mar;52(3):257-9. doi: 10.1097/00000542-198003000-00011. No abstract available.
- Background: PubMed 15830773Al-Qahtani AS, Messahel FM. Quality improvement in anesthetic practice--incidence of sore throat after using small tracheal tube. Middle East J Anaesthesiol. 2005 Feb;18(1):179-83.
- Individual participant dataSharing planned: No. We will not share any data about the participants with other researchers; but we will share the results after doing our analysis.
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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?
An observational study of Postoperative Sore Throat, run by Al-Azhar University at 1 site in Iraq.
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 4 inclusion and 8 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 16 Apr 2024. 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 Iraq. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ministry O Health (07811593388, hussein.hussein@alayen.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sore throat (time frame: 2, 6, 12, and 24 hrs. postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368843, which also lists 3 linked publications.
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 16 Apr 2024.