Post Operative Sore ThroatNCT05975346
Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study
An observational study of Post Operative Sore Throat, run by Sohag University.
Trial summary
Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the eighth most undesirable outcome in the postoperative period POST has a reported incidence of up to 62% following general anesthesia… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Post Operative Sore Throat
- What is being tested?
- Ketamine and saline nebulization
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jan 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 16 to 60 years
- All sexes
- Child, Adult
Study population: 1. Age 16-60 years. 2. Of both sex. 3. American Society of Anesthesiologists Physical Status (ASA PS) I-II. 4. Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.
Who may be able to join
- Age 16-60 years.
- Of both sex.
- American Society of Anesthesiologists Physical Status (ASA PS) I-II.
- Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.
Who cannot join
- a- History of chronic obstructive History of sore throat or upper respiratory tract infection.
- b- Intraoral and intrapharyngeal surgery. c- airway disease or Asthma. d- Mallampati grade more than II. e- Known allergic to study drug. f- More than one attempt is required for intubation. g- Hypertensive patients. h- Epileptic patients. i- cerebral palsy or any neurological disorders. j- Psychiatry patients. k- Cardiac patients. l- Perioperative use of anti-inflammatory drugs (Non-steroidal anti-inflammatory drug or steroids).
Trial locations and contacts
No sites are listed yet.
fawzy A Badawy, assistant professor contact
About this study
Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the eighth most undesirable outcome in the postoperative period POST has a reported incidence of up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with tracheal intubation than in GA with the supraglottic airway Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects
- Conditions
- Post Operative Sore Throat
- Being tested
- Ketamine, saline nebulization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
description
saline nebulizationOther
description
| Study group | Role | What they receive |
|---|---|---|
| (K) Ketamine group | 40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization Receives: Drug: Ketamine | |
| (S) Saline group | 40 patients will receive saline nebulization (5ml). Receives: Other: saline nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence and severity of POST
the study is to measure the incidence and severity of POST at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively. in adult patients undergoing surgery of a duration less than 2h.
Measured: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
Secondary outcomes (1)
evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.
evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.
Measured: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 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 Post Operative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ahmed Abdellatif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975346
- Sponsor's protocol ID
- soh-Med-23-07-20MS
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cairns A, Battleday FM, Velikova G, Brunelli A, Bell H, Favo J, Patella M, Lindner O, Pompili C. General patient satisfaction after elective and acute thoracic surgery is associated with postoperative complications. J Thorac Dis. 2020 May;12(5):2088-2095. doi: 10.21037/jtd-19-3345b.
PubMed 32642112Hailu S, Shiferaw A, Regasa T, Getahun YA, Mossie A, Besha A. Incidence of Postoperative Sore Throat and Associated Factors Among Pediatric Patients Undergoing Surgery Under General Anesthesia at Hawassa University Comprehensive Specialized Hospital, a Prospective Cohort Study. Int J Gen Med. 2023 Feb 18;16:589-598. doi: 10.2147/IJGM.S397519. eCollection 2023.
PubMed 36845340Thomas D, Bejoy R, Zabrin N, Beevi S. Preoperative ketamine nebulization attenuates the incidence and severity of postoperative sore throat: A randomized controlled clinical trial. Saudi J Anaesth. 2018 Jul-Sep;12(3):440-445. doi: 10.4103/sja.SJA_47_18.
PubMed 30100844
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05975346
- Acronym / sponsor ID
- soh-Med-23-07-20MS
- Conditions
- Post Operative Sore Throat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 3 Aug 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.
Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the eighth most undesirable outcome in the postoperative period POST has a reported incidence of up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with tracheal intubation than in GA with the supraglottic airway Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (K) Ketamine group | – | Drug: Ketamine40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization |
| (S) Saline group | – | Other: saline nebulization40 patients will receive saline nebulization (5ml). |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 1. Age 16-60 years. 2. Of both sex. 3. American Society of Anesthesiologists Physical Status (ASA PS) I-II. 4. Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.
Key inclusion criteria (4 listed)
- Age 16-60 years.
- Of both sex.
- American Society of Anesthesiologists Physical Status (ASA PS) I-II.
- Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.
Key exclusion criteria (2 listed)
- a- History of chronic obstructive History of sore throat or upper respiratory tract infection.
- b- Intraoral and intrapharyngeal surgery. c- airway disease or Asthma. d- Mallampati grade more than II. e- Known allergic to study drug. f- More than one attempt is required for intubation. g- Hypertensive patients. h- Epileptic patients. i- cerebral palsy or any neurological disorders. j- Psychiatry patients. k- Cardiac patients. l- Perioperative use of anti-inflammatory drugs (Non-steroidal anti-inflammatory drug or steroids).
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 |
|---|---|---|
| Ketaminedescription | Drug | (K) Ketamine group |
| saline nebulizationdescription | Other | (S) Saline group |
Primary outcome
the incidence and severity of POST
Time frame: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
the study is to measure the incidence and severity of POST at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively. in adult patients undergoing surgery of a duration less than 2h.
1 secondary outcome
evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.
Time frame: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 32642112Cairns A, Battleday FM, Velikova G, Brunelli A, Bell H, Favo J, Patella M, Lindner O, Pompili C. General patient satisfaction after elective and acute thoracic surgery is associated with postoperative complications. J Thorac Dis. 2020 May;12(5):2088-2095. doi: 10.21037/jtd-19-3345b.
- Background: PubMed 36845340Hailu S, Shiferaw A, Regasa T, Getahun YA, Mossie A, Besha A. Incidence of Postoperative Sore Throat and Associated Factors Among Pediatric Patients Undergoing Surgery Under General Anesthesia at Hawassa University Comprehensive Specialized Hospital, a Prospective Cohort Study. Int J Gen Med. 2023 Feb 18;16:589-598. doi: 10.2147/IJGM.S397519. eCollection 2023.
- Background: PubMed 30100844Thomas D, Bejoy R, Zabrin N, Beevi S. Preoperative ketamine nebulization attenuates the incidence and severity of postoperative sore throat: A randomized controlled clinical trial. Saudi J Anaesth. 2018 Jul-Sep;12(3):440-445. doi: 10.4103/sja.SJA_47_18.
- Individual participant dataSharing planned: Undecided
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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.
fawzy A Badawy, assistant professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Sore Throat, run by Sohag University.
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 2 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Doaa A Abdellatif, resident (01119950167, doaaahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence and severity of POST (time frame: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.). 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 NCT05975346, 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 3 Aug 2023.