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

• Sponsor: Keimyung University Dongsan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03173339
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 33.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hip Arthroplasty	Procedure: Endotracheal intubation using laryngoscope; Drug: High remifentanil; Drug: Low remifentanil; Drug: High sevoflurane; Drug: Low sevoflurane	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Influence of Remifentanil on Postoperative Sore Throat in Patients Undergoing General Anesthesia
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Aug 24, 2017
• Actual Study Completion Date: Aug 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low remifentanil and high sevoflurane Remifentanil was administered as 0.1 mcg/kg/min. 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 %.	Procedure: Endotracheal intubation using laryngoscope; Endotracheal intubation was done using laryngoscope for general anesthesia.; Drug: Low remifentanil; Remifentanil was administered as 0.1 mcg/kg/min.; Drug: 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 %.
Experimental: High remifentanil and low sevoflurane Sevoflurane was administered as 0.5 MAC. 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.	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.; Drug: Low sevoflurane; Sevoflurane was administered as 0.5 MAC.

Outcome Measures

Primary Outcome Measures

1. Number of participants with sore throat [At 24 hr]

Secondary Outcome Measures

1. Number of participants with sore throat [At 0, 2, 4 and 24 hr]

2. Number of participants with hoarseness [At 0, 2, 4 and 24 hr]

3. Number of participants with cough [At 0, 2, 4 and 24 hr]

4. Number of participants with nausea [At 0, 2, 4 and 24 hr]

5. Number of participants with vomiting [At 0, 2, 4 and 24 hr]

6. Number of participants with additional pain medication [At 0, 2, 4 and 24 hr]

7. Visual analogue scale of postoperative pain [At 0, 2, 4 and 24 hr]

8. Number of participants with shivering [At 0, 2, 4 and 24 hr]

9. Requirements of analgesics [At 0, 2, 4 and 24 hr]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keimyung University	Daegu	Non-US/Canada	Korea, Republic of	137-040

Sponsors and Collaborators

• Keimyung University Dongsan Medical Center

Investigators

• Principal Investigator: Hyun-Chang Kim, MD. Ph. D., Keimyung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keimyung University Dongsan Medical Center
• ClinicalTrials.gov Identifier: NCT03173339
• Other Study ID Numbers: HighRemiSoreThroat
• First Posted: Jun 1, 2017
• Last Update Posted: Aug 25, 2017
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Keimyung University Dongsan Medical Center: intubation; pharyngitis; remifentanil
• Additional relevant MeSH terms: Pharyngitis; Remifentanil; Sevoflurane

Study Results

No Results Posted as of Aug 25, 2017