Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

Thyroid Surgery Clinical Trial

Official title:

Effect of Tramadol on Postoperative Sore Throat in Thyroid Surgery Under General Anesthesia With Endotracheal Intubation: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991493
• Other study ID #: QPOST
• Status: Recruiting
• Phase: Phase 4
• Start date: September 10, 2021
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Affiliated Cancer Hospital of Shantou University Medical College
• Contact: zegeng su, master
• Phone: 13929688978
• Email: goctor[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: March 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Intubation Intratracheal
• Pharyngitis
• Post-operative Sore Throat
• Thyroid Diseases
• Thyroid Surgery

Intervention

Drug:
• Tramadol hydrochloride
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.

Other:
• Normal Saline
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.

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital of Shantou University Medical College Medical	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital of Shantou University Medical College

Country where clinical trial is conducted

China, 

References & Publications (4)

El-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. — View Citation

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. — View Citation

Lin 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. — View Citation

Tekelioglu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Post-operative sore throat	The incidence of postoperative sore throat at 24 hours after extubation.	24 hours following extubation of endotracheal tube
Secondary	The Incidence of Post-operative sore throat	The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.	30 Minutes following extubation of endotracheal tube
Secondary	The Incidence of Post-operative sore throat	The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.	4 hours following extubation of endotracheal tube
Secondary	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	30 Minutes ,4 hours and 24 hours following extubation of endotracheal tube
Secondary	The incidence of of postoperative hoarseness.	The incidence of of postoperative hoarseness at 0 hours,4 hours and 24 hours after extubation.	30 Minutes ,4 hours and 24 hours following extubation of endotracheal tube
Secondary	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	30 Minutes ,4 hours and 24 hours following extubation of endotracheal tube