Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia

Hip Arthroplasty Clinical Trial

Official title:

Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173339
• Other study ID #: HighRemiSoreThroat
• Status: Completed
• Phase: N/A
• First received: May 29, 2017
• Last updated: August 23, 2017
• Start date: June 1, 2017
• Est. completion date: August 24, 2017

Study information

• Verified date: May 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 24, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA I-III

• Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

• Difficult airway

• Rapid sequence induction

• Recent sore throat

• Recent upper respiratory infection

• Asthma

• Chronic obstructive pulmonary disease

• Chronic cough

• Pregnancy

• Allergy to remifentanil

• Friable teeth

• History of head and neck surgery

• Multiple intubation attempts

• Regional anesthetic agents

• Gastric tube

• Dexamethasone

Related Conditions & MeSH terms

• Hip Arthroplasty
• Pharyngitis

Intervention

Procedure:
• Endotracheal intubation using laryngoscope
Endotracheal intubation was done using laryngoscope for general anesthesia.

Drug:
• High remifentanil
Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.
• Low remifentanil
Remifentanil was administered as 0.1 mcg/kg/min.
• High sevoflurane
Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.
• Low sevoflurane
Sevoflurane was administered as 0.5 MAC.

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University	Daegu	Non-US/Canada

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with sore throat		At 24 hr
Secondary	Number of participants with sore throat		At 0, 2, 4 and 24 hr
Secondary	Number of participants with hoarseness		At 0, 2, 4 and 24 hr
Secondary	Number of participants with cough		At 0, 2, 4 and 24 hr
Secondary	Number of participants with nausea		At 0, 2, 4 and 24 hr
Secondary	Number of participants with vomiting		At 0, 2, 4 and 24 hr
Secondary	Number of participants with additional pain medication		At 0, 2, 4 and 24 hr
Secondary	Visual analogue scale of postoperative pain		At 0, 2, 4 and 24 hr
Secondary	Number of participants with shivering		At 0, 2, 4 and 24 hr
Secondary	Requirements of analgesics		At 0, 2, 4 and 24 hr