Intubation Intratracheal, Post-operative Sore Throat, Thyroid Surgery
Conditions
Keywords
Tramadol, Post-operative Sore Throat, Intubation, Intratracheal, thyroid surgery
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.
Interventions
DRUGTramadol 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.
OTHERNormal 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.
Sponsors
Affiliated Cancer Hospital of Shantou University Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The anesthesia provider will be blinded to the intervention group allocation. All patients will be blinded. The primary investigator will be blinded. The resident researcher who will be the outcome assessor will also be blinded. The care provider will be blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Post-operative sore throat | 24 hours following extubation of endotracheal tube | The incidence of postoperative sore throat at 24 hours after extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The severity of postoperative hoarseness | 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube | 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 |
| The Incidence of Post-operative sore throat | 30 Minutes following extubation of endotracheal tube | The incidence of postoperative sore throat at 0 hours and 4 hours after extubation. |
| The severity of Post-Operative Sore Throat | 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube | 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 |
| The incidence of of postoperative hoarseness. | 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube | The incidence of of postoperative hoarseness at 0 hours，4 hours and 24 hours after extubation. |
Countries
China
Contacts
Primary Contactzegeng su, master
Outcome results
None listed