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

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

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

Conditions
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Hip Arthroplasty

Intervention / Treatment
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* Procedure: Endotracheal intubation using laryngoscope
* Drug: High remifentanil
* Drug: Low remifentanil
* Drug: High sevoflurane
* Drug: Low sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low remifentanil and high sevoflurane<br>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<br>* Endotracheal intubation was done using laryngoscope for general anesthesia.<br>Drug: Low remifentanil<br>* Remifentanil was administered as 0.1 mcg/kg/min.<br>Drug: High sevoflurane<br>* 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 %.<br>|
| Experimental: High remifentanil and low sevoflurane<br>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<br>* Endotracheal intubation was done using laryngoscope for general anesthesia.<br>Drug: High remifentanil<br>* 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.<br>Drug: Low sevoflurane<br>* Sevoflurane was administered as 0.5 MAC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with sore throat |  | At 24 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with sore throat |  | At 0, 2, 4 and 24 hr | 
| Number of participants with hoarseness |  | At 0, 2, 4 and 24 hr | 
| Number of participants with cough |  | At 0, 2, 4 and 24 hr | 
| Number of participants with nausea |  | At 0, 2, 4 and 24 hr | 
| Number of participants with vomiting |  | At 0, 2, 4 and 24 hr | 
| Number of participants with additional pain medication |  | At 0, 2, 4 and 24 hr | 
| Visual analogue scale of postoperative pain |  | At 0, 2, 4 and 24 hr | 
| Number of participants with shivering |  | At 0, 2, 4 and 24 hr | 
| Requirements of analgesics |  | At 0, 2, 4 and 24 hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, pharyngitis, remifentanil