Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application

NCT ID: NCT03424356

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-04
• Study Completion Date: 2018-12-10

Brief 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.

Detailed 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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

lma with rocuronium bromide

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.

Group Type: EXPERIMENTAL

Rocuronium Bromide

Intervention Type: DRUG

0.15 mg/kg rocuronium bromide

Fentanyl

Intervention Type: DRUG

1mcg/kg for induction

Propofol

Intervention Type: DRUG

2-3mg/kg for anaesthetic induction

cystoscopy

Intervention Type: PROCEDURE

patients will treated with this surgical procedure

lma with saline solution

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.

Group Type: ACTIVE_COMPARATOR

Saline Solution

Intervention Type: DRUG

1-2 ml saline solution

Fentanyl

Intervention Type: DRUG

1mcg/kg for induction

Propofol

Intervention Type: DRUG

2-3mg/kg for anaesthetic induction

cystoscopy

Intervention Type: PROCEDURE

patients will treated with this surgical procedure

Interventions

Rocuronium Bromide

0.15 mg/kg rocuronium bromide

Intervention Type: DRUG

Saline Solution

1-2 ml saline solution

Intervention Type: DRUG

Fentanyl

1mcg/kg for induction

Intervention Type: DRUG

Propofol

2-3mg/kg for anaesthetic induction

Intervention Type: DRUG

cystoscopy

patients will treated with this surgical procedure

Intervention Type: PROCEDURE

Other Intervention Names

nueromusculer blocker; saline; narcotic analgesic; hypnotic agent; surgical prosedure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Ulgey

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ayşe ülgey, md

Role: STUDY_CHAIR

TC Erciyes University

Locations

Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

mustafa asan, md

Role: CONTACT

mustafaasan@yahoo.com

+905059352060

ayse ülgey, md

Role: CONTACT

aülgey38@gmail.com

+905378201751

Facility Contacts

mustafa asan, md

Role: primary

mustafaasan@yahoo.com

+905059352060

ayse ülgey, md

Role: backup

aülgey38@gmail.com

+905378201751

Other Identifiers

2017/15

Identifier Type: -

Identifier Source: org_study_id