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Clinical Trials/NCT06967896
NCT06967896RecruitingNot Applicable

A Randomized Controlled Trial Comparing Different Models of Tracheal Tube for Thyroid Surgery in Women

Anqing Municipal Hospital1 site in 1 country180 target enrollmentStarted: May 25, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
180
Locations
1
Primary Endpoint
The incidence of postoperative sore throat

Study Overview

Brief Summary

Objective:Compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.Methods: Investigators enrolled 180 female patients with American Society of Anesthesiologists (ASA) physical status I and III, aged 18-65 years, and scheduled for elective undergoing thyroid surgery with general anesthesia. The participants were randomly assigned into three groups(n=60 each group):Group A: Tracheal catheter group with an inner diameter of 6.0mm, Group B: Tracheal catheter group with an inner diameter of 6.5mm, Group C: Tracheal catheter group with an inner diameter of 7.0mm.The incidence and severity of postoperative sore throat were recorded in three groups at 1 h, 6 h, 24 h and 48 h after operation.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Thyroid surgery should be performed under general anesthesia (GA) at an appropriate time;
  • •ASA grade I-III;
  • •Aged 18-65 years;
  • •BMI less than 35Kg/m2
  • •In line with ethics, patients voluntarily accept this experiment and sign informed consent.

Exclusion Criteria

  • •Reflux esophagitis, preoperative sore throat, chronic pharyngitis, preoperative hoarseness, use of anticoagulants or corticosteroids, high risk of reflux or aspiration, dysphagia, previous oral or pharyngeal surgical intervention, bleeding disorder, severe heart, lung, liver and kidney dysfunction
  • •Upper respiratory tract infection occurred within 2 weeks before surgery
  • •Unable to insert ET (no more than two intubations)
  • •Patients with hoarseness or sore throat before surgery
  • •Language communication, hearing impairment or brain dysfunction such as stroke, unable to communicate

Arms & Interventions

6.0#

Insert the tracheal tube of model 6.0#

6.5#

Insert the tracheal tube of model 6.5#

7.0#

Insert the tracheal tube of model 7.0#

Outcomes

Primary Outcomes

The incidence of postoperative sore throat

Time Frame: at 1 hour, 6 hour, 24 hour and 48 hour after operation

The incidence of postoperative sore throat

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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