Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post-operative Sore Throat, Intubation Intratracheal, Thyroid Surgery

Intervention / Treatment
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* Drug: Tramadol hydrochloride
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured. | Other: Normal Saline<br>* 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.<br>|
| Experimental: pre-tramadol group<br>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. | Drug: Tramadol hydrochloride<br>* 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.<br>* Other names: Tramadol;|
| Active Comparator: post-tramadol group<br>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. | Drug: Tramadol hydrochloride<br>* 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.<br>* Other names: Tramadol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tramadol, Post-operative Sore Throat, Intubation, Intratracheal, thyroid surgery