Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application

Study Overview
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Brief Summary
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Cystoscopy is a simple, effective and reliable method in current urological practice. Anesthesia may be required in cystoscopy for therapeutic purpose, however it may not be necessary for diagnostic cystoscopy. General anesthesia, spinal anesthesia, epidural anaesthesia and senile block methods may be performed in therapeutic cystoscopy. Pain is main reason of failed cystoscopy. Sedo-analgesia and LMA are generally used for diagnostic cystoscopies. LMA is mostly placed under general anesthesia with the combination of propofol-fentanyl and volatile anesthetics. There is no need for muscle relaxant administration in LMA placement, as it is necessary for intubation. However if muscle relaxant is not used, side effects like hiccup, straining, cough, undesirable muscle movement, hypoxia and laryngeal spasm may be observed. For the improvement of the patient comfort the use of effective muscle relaxants are described in several studies in literature. This study aimed to reveal the quality of anesthesia, hemodynamics, surgical comfort, extra propofol need and recovery time while low dose of muscle relaxant rocuronium was added to propofol-fentanyl combination for LMA placement.

Detailed Description
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Cystoscopy is a simple, effective and reliable method in current urological practice for the diagnosis and treatment of urethral and bladder pathologies. Procedure is frequently used for the placement and replacement (removal) of double J stent in patients with ureteral stones . Cystoscopy may be used for the investigation of hematuria and dysuria and if needed for diagnostic biopsy as well as for therapeutic purpose in patients with bladder and prostate tumor. Anesthesia may be required in cystoscopy for therapeutic purpose, however it may not be necessary for diagnostic cystoscopy. General anesthesia, spinal anesthesia, epidural anesthesia and senile block methods may be performed in therapeutic systoscopy. Diagnostic cystoscopies may be performed via sedoanalgesia, local anesthetic spray administration, penile block or without any type of anesthesia. Female patients having short urethra are more compatible for local techniques or for the procedures without anesthesia. Pain is main reason of failed cystoscopy. Sedoanalgesia and LMA are generally used for diagnostic cystoscopies. LMA is mostly placed under general anesthesia with the combination of propofol-fentanyl and volatile anesthetics. There is no need for muscle relaxant administration in LMA placement, as it is necessary for intubation. However if muscle relaxant is not used, side effects like hiccup, straining, cough, undesirable muscle movement, hypoxia and laryngeal spasm may be observed. Placement of LMA may be difficult or sometimes impossible in some patients with limited mouth opening. These patients may experience complications like pain and burning in the mouth, pain in the ear, hoarse voice, swallowing difficulty because of difficult LMA placement in postoperative period. For the improvement of the patient comfort the use of effective muscle relaxants are described in several studies in literature. This study aimed to reveal the quality of anesthesia, hemodynamics, surgical comfort, extra propofol need and recovery time while low dose of muscle relaxant rocuronium was added to propofol-fentanyl combination for LMA placement.

Official Title
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Comparison of Effects of Low Dose Neuromuscular Blocker Added to Propofol Fentanyl Combination During Lma Procedures in Cystoscopy Patients

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Rocuronium Bromide
* Drug: Saline Solution
* Drug: Fentanyl
* Drug: Propofol
* Procedure: cystoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients ASA I-II patients Cystoscopy patients patients entubated with lariyngeal mask Exclusion Criteria: Female patients Asa III-IV patients Surgery duration is more than 2 hours Drug abusers Non compromising patients

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

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lma with rocuronium bromide<br>In study group, 2-3 mg/kg propofol, 1mcg/kg fentanyl and 0.15 mg/kg rocuronium bromide will be administered during lma insertion in cystoscopy procedure. | Drug: Rocuronium Bromide<br>* 0.15 mg/kg rocuronium bromide<br>* Other names: nueromusculer blocker;Drug: Fentanyl<br>* 1mcg/kg for induction<br>* Other names: narcotic analgesic;Drug: Propofol<br>* 2-3mg/kg for anaesthetic induction<br>* Other names: hypnotic agent;Procedure: cystoscopy<br>* patients will treated with this surgical procedure<br>* Other names: surgical prosedure;|
| Active Comparator: lma with saline solution<br>In control group, 2-3 mg/kg propofol, 1 mcg/kg fentanyl and saline(no rocuronium) will be administered during lma insertion in cystoscopy procedure. | Drug: Saline Solution<br>* 1-2 ml saline solution<br>* Other names: saline;Drug: Fentanyl<br>* 1mcg/kg for induction<br>* Other names: narcotic analgesic;Drug: Propofol<br>* 2-3mg/kg for anaesthetic induction<br>* Other names: hypnotic agent;Procedure: cystoscopy<br>* patients will treated with this surgical procedure<br>* Other names: surgical prosedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire | The quality of LMA placement with or without neuromusculer drug. | up to first 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire | after the surgery soar throat will be evaluated | up to first 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LMA, Rocuronium bromur, propofol