Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

Detailed Description
-----------------
In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.

Official Title
-----------------
Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia

Conditions
-----------------
Sore Throat

Intervention / Treatment
-----------------
* Drug: Rocuronium(deep)
* Drug: Rocuronium(moderate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requirement for mechanical ventilation under general anesthesia Exclusion Criteria: Hoarseness and sore throat existed before surgery Upper respiratory infection Known or predicted difficult airway Liver, renal disease Requirement of postoperative ventilator care the operation within 2hrs Laparoscopic surgery Other positions except supine during surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate muscle relaxation<br>Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute. | Drug: Rocuronium(moderate)<br>* In the group with deep relaxation during surgery, rocuronium is given by bolus dose(0.15mg/kg) induced a train of four count of 1-2.<br>|
| Experimental: Deep muscle relaxation<br>Rocuronium is administered to maintain deep relaxation during operation. | Drug: Rocuronium(deep)<br>* In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of postoperative sore throat | The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period | Within 24 hrs after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative sore throat | The presence of sore throat is assessed. | At 1,6, and 24 hrs after operation | 
| The severity of postoperative sore throat | The severity of sore throat is assessed by using a 100-point numerical ratig scale (NRS, 0 [no pain], 100 [worst pain imaginable]). | At 1,6, and 24 hrs after operation | 
| Incidence and severity of postoperative hoarseness | Hoarseness is defined as a voice quality different from the preoperative voice and graded as follows: none (no hoarseness), mild (recognized by the patient), moderate (obvious to the investigator), and severe (aphonia). | At 1,6, and 24 hrs after operation | 
| Postoperative analgesic consumption | The amount of patient-controlled analgesia and other analgesic medication used | Within 24 hrs after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle relaxant