A Phase 4 interventional study of Tramadol hydrochloride and Normal Saline in Post-operative Sore Throat, Intubation Intratracheal and Thyroid Surgery, sponsored by Affiliated Cancer Hospital of Shantou University Medical College. Status unknown at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Affiliated Cancer Hospital of Shantou University Medical College · Phase 4, Interventional, and Prevention
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.
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.
Affiliated Cancer Hospital of Shantou University Medical College is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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- 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.
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
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
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
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.
Also known as: Tramadol
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.
The Incidence of Post-operative sore throat
The incidence of postoperative sore throat at 24 hours after extubation.
Time frame: 24 hours 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
Plan to share: No
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tramadol
Affiliated Cancer Hospital of Shantou University Medical College