Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Not Applicable

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Device: cuff pressure

• Registration Number: NCT04247360
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

When general anesthesia is performed for surgery, tracheal intubation is performed. In order to ventilate after performing tracheal intubation, air is injected into the cuff attached to the tube to fill the gap between the tracheal tube and the patients's inner surface of trachea.

Even though, 20 to 30 cm H2O is known to be the appropriate pressure to prevent air leaks while preventing ischemic damage of tracheal mucosa. So, Researchers want to observe clinical differences in pressure at both ends of the safety zone of the cuff pressure.

Detailed Description

Patients who are scheduled for elective surgery/ general anesthesia are randomized to two groups.

l : cuff pressure - 20cmH2O ll : cuff pressure - 30cmH2O

After tracheal intubation with routine method, cuff pressure is continuously monitored with manometer. The anesthesia during surgery is maintained with 0.8 MAC of desflurane and continuous remifentanil. Clinical outcomes (sore throat, hoarseness and postoperative pain) are evaluated after 0 minutes, 2 hours, 4 hours, and 24 hours after surgery.

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-31
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• patients undergoing total hip replacement arthroplasty that require general anesthesia

Exclusion Criteria

• a patient who disagrees with the study
• tracheal stenosis
• operation time > 3 hours or < 1 hour 30 minutes
• difficult airway
• drug abuse, alcoholism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cuff pressure with 30cmH2O	cuff pressure	continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery
cuff pressure with 20cmH2O	cuff pressure	continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery

Primary Outcome Measures

Name	Time	Method
postoperative sore throat	At postoperative 24 hours	Number of participants with postoperative sore throat for postoperative 24 hours

Secondary Outcome Measures

Name	Time	Method
postoperative hoarseness	At postoperative 24 hours	Number of participants with postoperative hoarseness for postoperative 24 hours
nausea	At postoperative 24 hours	Number of participants with postoperative nausea for postoperative 24 hours
Requirements of analgesics	At postoperative 24 hours	Number of participants with analgesics use for postoperative 24 hours