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Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

Primary Purpose

Post-operative Sore Throat, Intubation Intratracheal, Thyroid Surgery

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tramadol hydrochloride
Normal Saline
Sponsored by
Affiliated Cancer Hospital of Shantou University Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Sore Throat focused on measuring Tramadol, Post-operative Sore Throat, Intubation, Intratracheal, thyroid surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Affiliated Cancer Hospital of Shantou University Medical College MedicalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo group

pre-tramadol group

post-tramadol group

Arm Description

5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured.

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.

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.

Outcomes

Primary Outcome Measures

The Incidence of Post-operative sore throat
The incidence of postoperative sore throat at 24 hours after extubation.

Secondary Outcome Measures

The Incidence of Post-operative sore throat
The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.
The Incidence of Post-operative sore throat
The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.
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
The incidence of of postoperative hoarseness.
The incidence of of postoperative hoarseness at 0 hours,4 hours and 24 hours after extubation.
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

Full Information

First Posted
July 27, 2021
Last Updated
August 31, 2023
Sponsor
Affiliated Cancer Hospital of Shantou University Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04991493
Brief Title
Effect of Tramadol on Postoperative Sore Throat After General Anesthesia
Official Title
Effect of Tramadol on Postoperative Sore Throat in Thyroid Surgery Under General Anesthesia With Endotracheal Intubation: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Cancer Hospital of Shantou University Medical College

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Sore Throat, Intubation Intratracheal, Thyroid Surgery
Keywords
Tramadol, Post-operative Sore Throat, Intubation, Intratracheal, thyroid surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured.
Arm Title
pre-tramadol group
Arm Type
Experimental
Arm Description
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.
Arm Title
post-tramadol group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tramadol hydrochloride
Other Intervention Name(s)
Tramadol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Incidence of Post-operative sore throat
Description
The incidence of postoperative sore throat at 24 hours after extubation.
Time Frame
24 hours following extubation of endotracheal tube
Secondary Outcome Measure Information:
Title
The Incidence of Post-operative sore throat
Description
The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.
Time Frame
30 Minutes following extubation of endotracheal tube
Title
The Incidence of Post-operative sore throat
Description
The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.
Time Frame
4 hours following extubation of endotracheal tube
Title
The severity of Post-Operative Sore Throat
Description
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
Title
The incidence of of postoperative hoarseness.
Description
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
Title
The severity of postoperative hoarseness
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender is one of the independent factors affecting postoperative sore throat. To reduce the bias from gender, we only considered female patients.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zegeng su, master
Phone
13929688978
Email
goctor@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zegeng su, master
Organizational Affiliation
Affiliated Cancer Hospital of Shantou University Medical College Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Cancer Hospital of Shantou University Medical College Medical
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zegeng su, master
Phone
13929688978
Email
goctor@163.com
First Name & Middle Initial & Last Name & Degree
xiang xu, master

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24124452
Citation
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.
Results Reference
background
PubMed Identifier
27158989
Citation
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.
Results Reference
background
PubMed Identifier
23521170
Citation
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.
Results Reference
background
PubMed Identifier
22089326
Citation
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.
Results Reference
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Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

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