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Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04247360
Enrollment
138
Registered
2020-01-30
Start date
2020-01-31
Completion date
2020-08-31
Last updated
2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Hip

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.

Interventions

maintaining cuff pressure according the groups

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative sore throatAt postoperative 24 hoursNumber of participants with postoperative sore throat for postoperative 24 hours

Secondary

MeasureTime frameDescription
postoperative hoarsenessAt postoperative 24 hoursNumber of participants with postoperative hoarseness for postoperative 24 hours
nauseaAt postoperative 24 hoursNumber of participants with postoperative nausea for postoperative 24 hours
Requirements of analgesicsAt postoperative 24 hoursNumber of participants with analgesics use for postoperative 24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026