Post-operative Sore ThroatPhase 4NCT04991493
Effect of Tramadol on Postoperative Sore Throat After General Anesthesia
A Phase 4 study testing Tramadol hydrochloride and Normal Saline in people with Post-operative Sore Throat and Intubation Intratracheal, run by Affiliated Cancer Hospital of Shantou University Medical College at 1 site in China.
Trial summary
Post operative sore throat after general anesthesia with endotracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. The investigators want to study the effect of tramadol on postoperative sore throat in general anesthesia with endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-operative Sore Throat, Intubation Intratracheal, Thyroid Surgery
- What is being tested?
- Tramadol hydrochloride and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2021to Jul 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.
Who cannot join
- History of thyroid surgery A history of preoperative sore throat; Pregnancy; Retrosternal goiter; Thyroid tumor invading trachea need trachea reconstruction; Potentially difficult airway; Clinical diagnosis of chronic sore throat; Clinical diagnosis of psychosis; Tracheotomy after operation； Transfer to intensive care unit after operation； Contraindications to tramadol； Body mass index (BMI) > 30kg/m^2.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Shantou University Medical College Medical
Shantou, Guangdong, 515041
zegeng su, master, 13929688978, goctor@163.com
xiang xu, master
About this study
Official title: Effect of Tramadol on Postoperative Sore Throat in Thyroid Surgery Under General Anesthesia With Endotracheal Intubation: A Randomized Controlled Trial
Post operative sore throat after general anesthesia with endotracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. The investigators want to study the effect of tramadol on postoperative sore throat in general anesthesia with endotracheal intubation.
Read the detailed description
Design: A prospective, randomized, controlled study. Setting: Single-center university hospital. Participants: The study included 168 patients undergoing thyroid surgery under general anesthesia with endotracheal intubation.
Interventions: The patients were allocated randomly into the following 3 groups: the control group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and another 5ml of normal saline was injected intravenously when the incision was washed and sutured；the pre-tramadol group: patients will be injected intravenously 5ml of tramadol (1mg / kg) 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. the post-tramadol group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and 5ml of tramadol (1mg / kg) was injected intravenously when the incision was washed and sutured. Postoperatively, all patients will receive standard treatment.
- Being tested
- Tramadol hydrochloride, Normal Saline
- Keywords
- Tramadol, Post-operative Sore Throat, Intubation, Intratracheal, thyroid surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol hydrochlorideDrug
Also called Tramadol
pre-tramadol group: 1mg/kg of tramadol will be intravenously injected 15 minutes before anesthesia.
post-tramadol group: 1mg/kg of tramadol will be intravenously injected when the incision was washed and sutured.
Normal SalineOther
pre-tramadol group: Normal Saline will be injected intravenously when the incision was washed and sutured.
post-tramadol group: Normal Saline will be injected intravenously 15 minutes before anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | 5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured. Receives: Other: Normal Saline |
| pre-tramadol group | Experimental | 5ml of tramadol containing 1mg / kg was injected intravenously 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. Receives: Drug: Tramadol hydrochloride |
| post-tramadol group | Active comparator | 5ml of normal saline was injected intravenously 15 minutes before anesthesia and 5ml of tramadol containing 1mg / kg was injected intravenously when the incision was washed and sutured. Receives: Drug: Tramadol hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Post-operative sore throat
The incidence of postoperative sore throat at 24 hours after extubation.
Measured: 24 hours following extubation of endotracheal tube
Secondary outcomes (5)
The Incidence of Post-operative sore throat
The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.
Measured: 30 Minutes following extubation of endotracheal tube
The Incidence of Post-operative sore throat
The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.
Measured: 4 hours following extubation of endotracheal tube
The severity of Post-Operative Sore Throat
Assessment of severity of postoperative sorethroat using scoring system, 0-No sore throat at any time since the extubation,1- Minimal sore throat,2- Moderate sore throat,3- Severe sore throat
Measured: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
The incidence of of postoperative hoarseness.
The incidence of of postoperative hoarseness at 0 hours，4 hours and 24 hours after extubation.
Measured: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
The severity of postoperative hoarseness
Assessment of postoperative hoarseness using scoring system,0- No evidence of hoarseness at any time since the extubation,1-No evidence of hoarseness at the time of interview,2-Hoarseness at the time of interview noted by patient only, 3- Hoarseness that is easily noted at the time of interview
Measured: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start10 Sep 2021
- Primary completion1 Nov 2023
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-operative Sore ThroatStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital of Shantou University Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zegeng su, Affiliated Cancer Hospital of Shantou University Medical College
- Investigators
- zegeng su, master, Principal investigator, Affiliated Cancer Hospital of Shantou University Medical College Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991493
- Sponsor's protocol ID
- QPOST
- Status last verified
- May 2024
- First submitted
- 27 Jul 2021
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu B, Bao R, Wang X, Liu S, Tao T, Xie Q, Yu X, Li J, Bo L, Deng X. The size of endotracheal tube and sore throat after surgery: a systematic review and meta-analysis. PLoS One. 2013 Oct 4;8(10):e74467. doi: 10.1371/journal.pone.0074467. eCollection 2013.
PubMed 24124452El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
PubMed 27158989Tekelioglu UY, Apuhan T, Akkaya A, Demirhan A, Yildiz I, Simsek T, Gok U, Kocoglu H. Comparison of topical tramadol and ketamine in pain treatment after tonsillectomy. Paediatr Anaesth. 2013 Jun;23(6):496-501. doi: 10.1111/pan.12148. Epub 2013 Mar 23.
PubMed 23521170Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.
PubMed 22089326Su Z, Huang J, Xu X, Yang B, Lv X, Zhang S, Wang X, Chen E, Xu Y, Lin Y, Huang X, Su Y, Li L, Yin Y, Guo Z, Tong L, Huang M, Xu X. Tramadol and postoperative sore throat after tracheal intubation in thyroid surgery - a randomized controlled trial. BMC Anesthesiol. 2025 Dec 22;25(1):610. doi: 10.1186/s12871-025-03487-z.
PubMed 41430574
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tramadol on Postoperative Sore Throat in Thyroid Surgery Under General Anesthesia With Endotracheal Intubation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04991493
- Acronym / sponsor ID
- QPOST
- Keywords
- Tramadol, Post-operative Sore Throat, Intubation, Intratracheal, thyroid surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital of Shantou University Medical CollegeUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 5 Aug 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.
Post operative sore throat after general anesthesia with endotracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. The investigators want to study the effect of tramadol on postoperative sore throat in general anesthesia with endotracheal intubation.
Detailed description
Design: A prospective, randomized, controlled study. Setting: Single-center university hospital. Participants: The study included 168 patients undergoing thyroid surgery under general anesthesia with endotracheal intubation.
Interventions: The patients were allocated randomly into the following 3 groups: the control group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and another 5ml of normal saline was injected intravenously when the incision was washed and sutured；the pre-tramadol group: patients will be injected intravenously 5ml of tramadol (1mg / kg) 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. the post-tramadol group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and 5ml of tramadol (1mg / kg) was injected intravenously when the incision was washed and sutured. Postoperatively, all patients will receive standard treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Normal Saline5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured. |
| pre-tramadol group | Experimental | Drug: Tramadol hydrochloride5ml of tramadol containing 1mg / kg was injected intravenously 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. |
| post-tramadol group | Active comparator | Drug: Tramadol hydrochloride5ml of normal saline was injected intravenously 15 minutes before anesthesia and 5ml of tramadol containing 1mg / kg was injected intravenously when the incision was washed and sutured. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.
Key exclusion criteria (1 listed)
- History of thyroid surgery A history of preoperative sore throat; Pregnancy; Retrosternal goiter; Thyroid tumor invading trachea need trachea reconstruction; Potentially difficult airway; Clinical diagnosis of chronic sore throat; Clinical diagnosis of psychosis; Tracheotomy after operation； Transfer to intensive care unit after operation； Contraindications to tramadol； Body mass index (BMI) > 30kg/m^2.
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 |
|---|---|---|
| Tramadol hydrochlorideAlso: Tramadolpre-tramadol group: 1mg/kg of tramadol will be intravenously injected 15 minutes before anesthesia. post-tramadol group: 1mg/kg of tramadol will be intravenously injected when the incision was washed and sutured. | Drug | post-tramadol group, pre-tramadol group |
| Normal Salinepre-tramadol group: Normal Saline will be injected intravenously when the incision was washed and sutured. post-tramadol group: Normal Saline will be injected intravenously 15 minutes before anesthesia. | Other | Placebo group |
Primary outcome
The Incidence of Post-operative sore throat
Time frame: 24 hours following extubation of endotracheal tube
The incidence of postoperative sore throat at 24 hours after extubation.
5 secondary outcomes
The Incidence of Post-operative sore throat
Time frame: 30 Minutes following extubation of endotracheal tube
The Incidence of Post-operative sore throat
Time frame: 4 hours following extubation of endotracheal tube
The severity of Post-Operative Sore Throat
Time frame: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
The incidence of of postoperative hoarseness.
Time frame: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
The severity of postoperative hoarseness
Time frame: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 24124452Hu B, Bao R, Wang X, Liu S, Tao T, Xie Q, Yu X, Li J, Bo L, Deng X. The size of endotracheal tube and sore throat after surgery: a systematic review and meta-analysis. PLoS One. 2013 Oct 4;8(10):e74467. doi: 10.1371/journal.pone.0074467. eCollection 2013.
- Background: PubMed 27158989El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
- Background: PubMed 23521170Tekelioglu UY, Apuhan T, Akkaya A, Demirhan A, Yildiz I, Simsek T, Gok U, Kocoglu H. Comparison of topical tramadol and ketamine in pain treatment after tonsillectomy. Paediatr Anaesth. 2013 Jun;23(6):496-501. doi: 10.1111/pan.12148. Epub 2013 Mar 23.
- Background: PubMed 22089326Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.
- Derived from this study: PubMed 41430574Su Z, Huang J, Xu X, Yang B, Lv X, Zhang S, Wang X, Chen E, Xu Y, Lin Y, Huang X, Su Y, Li L, Yin Y, Guo Z, Tong L, Huang M, Xu X. Tramadol and postoperative sore throat after tracheal intubation in thyroid surgery - a randomized controlled trial. BMC Anesthesiol. 2025 Dec 22;25(1):610. doi: 10.1186/s12871-025-03487-z.
- 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.
zegeng su, master principal investigator
Affiliated Cancer Hospital of Shantou University Medical College Medical
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 Tramadol hydrochloride and Normal Saline in people with Post-operative Sore Throat and Intubation Intratracheal, run by Affiliated Cancer Hospital of Shantou University Medical College at 1 site in China.
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 13 May 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 China. 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 zegeng su, master (13929688978, goctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Post-operative sore throat (time frame: 24 hours following extubation of endotracheal tube). 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 NCT04991493, which also lists 5 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 13 May 2024.