Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424356
• Other study ID #: 2017/15
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: June 2018
• Source: TC Erciyes University
• Contact: mustafa asan, md
• Phone: +905059352060
• Email: mustafaasan[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 10, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male patients

2. ASA I-II patients

3. Cystoscopy patients

4. patients entubated with lariyngeal mask

Exclusion Criteria:

1. Female patients

2. Asa III-IV patients

3. Surgery duration is more than 2 hours

4. Drug abusers

5. Non compromising patients

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Rocuronium Bromide
0.15 mg/kg rocuronium bromide
• Saline Solution
1-2 ml saline solution
• Fentanyl
1mcg/kg for induction
• Propofol
2-3mg/kg for anaesthetic induction

Procedure:
• cystoscopy
patients will treated with this surgical procedure

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire	The quality of LMA placement with or without neuromusculer drug.	up to first 60 minutes
Secondary	questionnaire	after the surgery soar throat will be evaluated	up to first 24 hours