Effect of Tramadol on Postoperative Sore Throat After General Anesthesia

NCT04991493 | Recruiting Phase 4

• 1 other identifier: QPOST
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Sore Throat; Intubation Intratracheal; Thyroid Surgery

Keywords

Tramadol; Post-operative Sore Throat; Intubation, Intratracheal; thyroid surgery

Outcome Measures

Primary Outcomes (1)

• The Incidence of Post-operative sore throat

  The incidence of postoperative sore throat at 24 hours after extubation.

  24 hours following extubation of endotracheal tube

Secondary Outcomes (5)

• The Incidence of Post-operative sore throat

  30 Minutes following extubation of endotracheal tube

• The Incidence of Post-operative sore throat

  4 hours following extubation of endotracheal tube

• The severity of Post-Operative Sore Throat

  30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube

• The incidence of of postoperative hoarseness.

  30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube

• The severity of postoperative hoarseness

  30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

EXPERIMENTAL

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

post-tramadol group

ACTIVE COMPARATOR

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

Interventions

Tramadol hydrochloride DRUG

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.

Also known as: Tramadol

post-tramadol group; pre-tramadol group

Normal Saline OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Gender is one of the independent factors affecting postoperative sore throat. To reduce the bias from gender, we only considered female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Female with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Affiliated Cancer Hospital of Shantou University Medical College: lead

Study Sites (1)

Affiliated Cancer Hospital of Shantou University Medical College Medical

Shantou, Guangdong, 515041, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 24124452 BACKGROUND

• 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.

  PMID: 27158989 BACKGROUND

• 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.

  PMID: 23521170 BACKGROUND

• 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.

  PMID: 22089326 BACKGROUND

MeSH Terms

Interventions

Tramadol; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• zegeng su, master

  Affiliated Cancer Hospital of Shantou University Medical College Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zegeng su, master

CONTACT

13929688978; goctor@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor/ Master of medicine

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 5, 2021
• Study Start: September 10, 2021
• Primary Completion: November 1, 2023
• Study Completion: July 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)