Clinical trial NCT04991493: Effect of Tramadol on Postoperative Sore Throat After General Anesthesia
Official title: Effect of Tramadol on Postoperative Sore Throat in Thyroid Surgery Under General Anesthesia With Endotracheal Intubation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post-operative Sore Throat
Intubation Intratracheal
Thyroid Surgery
Keywords: Tramadol
Post-operative Sore Throat
Intubation, Intratracheal
thyroid surgery
Lead sponsor: Affiliated Cancer Hospital of Shantou University Medical College
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Incidence of Post-operative sore throat
timeFrame: 24 hours following extubation of endotracheal tube
Secondary outcomes:
measure: The Incidence of Post-operative sore throat
timeFrame: 30 Minutes following extubation of endotracheal tube
measure: The Incidence of Post-operative sore throat
timeFrame: 4 hours following extubation of endotracheal tube
measure: The severity of Post-Operative Sore Throat
timeFrame: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
measure: The incidence of of postoperative hoarseness.
timeFrame: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
measure: The severity of postoperative hoarseness
timeFrame: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
Other outcomes:
Locations:
city: Shantou
country: China
facility: Affiliated Cancer Hospital of Shantou University Medical College Medical
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital of Shantou University Medical College Medical
name: zegeng su, master
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.