Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2023

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

  • 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.
  • Other: 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, Groups and Cohorts

  • Placebo Comparator: Placebo group
    • 5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured.
  • Experimental: pre-tramadol group
    • 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.
  • Active Comparator: post-tramadol group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The Incidence of Post-operative sore throat
    • Time Frame: 24 hours following extubation of endotracheal tube
    • The incidence of postoperative sore throat at 24 hours after extubation.

Secondary Measures

  • The Incidence of Post-operative sore throat
    • Time Frame: 30 Minutes following extubation of endotracheal tube
    • The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.
  • The Incidence of Post-operative sore throat
    • Time Frame: 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
    • Time Frame: 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.
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Gender is one of the independent factors affecting postoperative sore throat. To reduce the bias from gender, we only considered female patients.

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Affiliated Cancer Hospital of Shantou University Medical College
  • Provider of Information About this Clinical Study
    • Principal Investigator: zegeng su, Attending doctor/ Master of medicine – Affiliated Cancer Hospital of Shantou University Medical College
  • Overall Official(s)
    • zegeng su, master, Principal Investigator, Affiliated Cancer Hospital of Shantou University Medical College Medical
  • Overall Contact(s)
    • zegeng su, master, 13929688978, goctor@163.com

References

Hu B, Bao R, Wang X, Liu S, Tao T, Xie Q, Yu X, Li J, Bo L, Deng X. The size of endotracheal tube and sore throat after surgery: a systematic review and meta-analysis. PLoS One. 2013 Oct 4;8(10):e74467. doi: 10.1371/journal.pone.0074467. eCollection 2013.

El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.

Tekelioglu UY, Apuhan T, Akkaya A, Demirhan A, Yildiz I, Simsek T, Gok U, Kocoglu H. Comparison of topical tramadol and ketamine in pain treatment after tonsillectomy. Paediatr Anaesth. 2013 Jun;23(6):496-501. doi: 10.1111/pan.12148. Epub 2013 Mar 23.

Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.

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