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Clinical trial

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

ID
Name
QPOST
Description
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.
Trial arms
Trial start
2021-09-10
Estimated PCD
2023-11-01
Trial end
2024-07-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
post-tramadol group, pre-tramadol group
Other names:
Tramadol
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.
Arms:
Placebo group
Size
168
Primary endpoint
The Incidence of Post-operative sore throat
24 hours following extubation of endotracheal tube
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 168, 'type': 'ESTIMATED'}}
Updated at
2024-05-13

1 organization

1 product

3 indications

Organization
Affiliated Cancer Hospital of Shantou University Medical College
Product
Tramadol
Indication
Postoperative Sore Throat
Indication
Intubation Intratracheal
Indication
Thyroid Surgery