Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

May 10, 2024 updated by: zegeng su, Affiliated Cancer Hospital of Shantou University Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: zegeng su, master
  • Phone Number: 13929688978
  • Email: goctor@163.com

Study Locations

  • China
    • Guangdong
      • Shantou, Guangdong, China, 515041
        • Recruiting
        • Affiliated Cancer Hospital of Shantou University Medical College Medical
        • Contact:
        • Sub-Investigator:
          • xiang xu, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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 Names:
  • Tramadol
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.
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 Names:
  • Tramadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours following extubation of endotracheal tube

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 Minutes following extubation of endotracheal tube
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.
4 hours following extubation of endotracheal tube
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
30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
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.
30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube
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
30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Cancer Hospital of Shantou University Medical College

Investigators

  • Principal Investigator: zegeng su, master, Affiliated Cancer Hospital of Shantou University Medical College Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Actual)

November 1, 2023

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QPOST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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