Sore ThroatPhase 3NCT04955158
Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery
A Phase 3 study testing Dexmedetomidine, Ketamine and saline 0.9% in people with Sore Throat, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (FESS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- Dexmedetomidine, Ketamine and saline 0.9%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Aug 2021to 15 Feb 2023
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of both sex with American Society of Anesthesiologists (ASA) physical status I-II
- Elective functional endoscopic sinus surgery (FESS) with endotracheal intubation.
Who cannot join
- A history of preoperative sore throat.
- Upper respiratory tract illness
- Potentially difficult airway
- Patients with history of neck, respiratory or digestive tract pathology
- Chronic smokers
- Using steroid within the last 48 hour
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Dexmedetomidine Versus Ketamine Soaked Pharyngeal Packing on Postoperative Sore Throat in Functional Endoscopic Sinus Surgery: a Randomized Double Blind Trial
The aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (FESS).
Read the detailed description
A written informed consent was taken from the patients.patients will be randomly assigned to three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal packs were situated under direct vision. Throat packs made of gauze with a length of 20 cm and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml normal saline. The packings were placed by the surgeon blinded to the study groups.
1-Dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and \& endotracheal tube (ETT).
2-Ketamine group: 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
3-Control group: 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
- Conditions
- Sore Throat
- Being tested
- Dexmedetomidine, Ketamine, saline 0.9%
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
KetamineDrug
Also called ketalar
50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
saline 0.9%Other
Also called Normal saline
20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 75 µg dexmedetomidine soaked pharyngeal pack Receives: Drug: Dexmedetomidine |
| Ketamine | Experimental | 50 mg ketamine soaked pharyngeal pack Receives: Drug: Ketamine |
| Saline placebo | Experimental | 20 ml 0.9% saline soaked pharyngeal pack Receives: Other: saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative sore throat (POST)
On arrival in the post anesthesia care unit, the patient was immediately evaluated for the presence of sore throat (time 0 hour) using a standardized scale. The severity of POST was graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only with questioning), 2 being moderate sore throat (complains on their own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). Evaluations occurred at 0, 1, 2, 4, 6, 12 and 24 hours postoperatively.
Measured: 24 hour after surgery
Secondary outcomes (1)
Postoperative nausea and vomiting (PONV) score
PONV score was assessed and documented using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; 4 mg IV ondansetron for occurred nausea \& vomiting.
Measured: 2 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start19 Aug 2021
- Primary completion1 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
- Investigators
- Omar Soliman, MD, Principal investigator, Omar makram
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955158
- Sponsor's protocol ID
- 17101486
- Status last verified
- Apr 2023
- First submitted
- 1 Jul 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
PubMed 12066737
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexmedetomidine Versus Ketamine Soaked Pharyngeal Packing on Postoperative Sore Throat in Functional Endoscopic Sinus Surgery: a Randomized Double Blind Trial
- ClinicalTrials.gov ID
- NCT04955158
- Acronym / sponsor ID
- 17101486
- Conditions
- Sore Throat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 8 Jul 2021 (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 randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (FESS).
Detailed description
A written informed consent was taken from the patients.patients will be randomly assigned to three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal packs were situated under direct vision. Throat packs made of gauze with a length of 20 cm and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml normal saline. The packings were placed by the surgeon blinded to the study groups.
1-Dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and \& endotracheal tube (ETT).
2-Ketamine group: 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
3-Control group: 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine75 µg dexmedetomidine soaked pharyngeal pack |
| Ketamine | Experimental | Drug: Ketamine50 mg ketamine soaked pharyngeal pack |
| Saline placebo | Experimental | Other: saline 0.9%20 ml 0.9% saline soaked pharyngeal pack |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults of both sex with American Society of Anesthesiologists (ASA) physical status I-II
- Elective functional endoscopic sinus surgery (FESS) with endotracheal intubation.
Key exclusion criteria (7 listed)
- A history of preoperative sore throat.
- Upper respiratory tract illness
- Potentially difficult airway
- Patients with history of neck, respiratory or digestive tract pathology
- Chronic smokers
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT. | Drug | Dexmedetomidine |
| KetamineAlso: ketalar50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT. | Drug | Ketamine |
| saline 0.9%Also: Normal saline20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT. | Other | Saline placebo |
Primary outcome
Incidence of postoperative sore throat (POST)
Time frame: 24 hour after surgery
On arrival in the post anesthesia care unit, the patient was immediately evaluated for the presence of sore throat (time 0 hour) using a standardized scale. The severity of POST was graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only with questioning), 2 being moderate sore throat (complains on their own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). Evaluations occurred at 0, 1, 2, 4, 6, 12 and 24 hours postoperatively.
1 secondary outcome
Postoperative nausea and vomiting (PONV) score
Time frame: 2 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 12066737Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
- 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.
Omar Soliman, MD principal investigator
Omar makram
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine, Ketamine and saline 0.9% in people with Sore Throat, run by Assiut 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 13 Apr 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative sore throat (POST) (time frame: 24 hour after surgery). 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 NCT04955158, which also lists 1 linked publication.
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 13 Apr 2023.