Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

Phase 4

Recruiting

• Conditions: Thyroid Surgery; Post-operative Sore Throat; Intubation Intratracheal
• Interventions: Other: Normal Saline; Drug: Tramadol hydrochloride

• Registration Number: NCT04991493
• Lead Sponsor: Affiliated Cancer Hospital of Shantou University Medical College

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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-05
• Study Start: 2021-09-10
• Primary Completion: 2023-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Normal Saline	5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured.
pre-tramadol group	Tramadol hydrochloride	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.
post-tramadol group	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The Incidence of Post-operative sore throat	4 hours 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.
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

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Shantou University Medical College Medical; 🇨🇳 Shantou, Guangdong, China