Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application

NCT03424356 | Unknown DMC

• 1 other identifier: 2017/15
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

LMA; Rocuronium bromur; propofol

Outcome Measures

Primary Outcomes (1)

• questionnaire

  The quality of LMA placement with or without neuromusculer drug.

  up to first 60 minutes

Secondary Outcomes (1)

• questionnaire

  up to first 24 hours

Study Arms (2)

lma with rocuronium bromide

EXPERIMENTAL

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; Drug: Fentanyl; Drug: Propofol; Procedure: cystoscopy

lma with saline solution

ACTIVE COMPARATOR

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; Drug: Fentanyl; Drug: Propofol; Procedure: cystoscopy

Interventions

Rocuronium Bromide DRUG

0.15 mg/kg rocuronium bromide

Also known as: nueromusculer blocker

lma with rocuronium bromide

Saline Solution DRUG

1-2 ml saline solution

Also known as: saline

lma with saline solution

Fentanyl DRUG

1mcg/kg for induction

Also known as: narcotic analgesic

lma with rocuronium bromide; lma with saline solution

Propofol DRUG

2-3mg/kg for anaesthetic induction

Also known as: hypnotic agent

lma with rocuronium bromide; lma with saline solution

cystoscopy PROCEDURE

patients will treated with this surgical procedure

Also known as: surgical prosedure

lma with rocuronium bromide; lma with saline solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients
• ASA I-II patients
• Cystoscopy patients
• patients entubated with lariyngeal mask

You may not qualify if:

• Female patients
• Asa III-IV patients
• Surgery duration is more than 2 hours
• Drug abusers
• Non compromising patients

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Rocuronium; Saline Solution; Sodium Chloride; Fentanyl; Narcotics; Propofol; Hypnotics and Sedatives; Cystoscopy

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• ayşe ülgey, md

  TC Erciyes University

  STUDY CHAIR

Central Study Contacts

mustafa asan, md

CONTACT

+905059352060; mustafaasan@yahoo.com

ayse ülgey, md

CONTACT

+905378201751; aülgey38@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: February 7, 2018
• Study Start: January 4, 2017
• Primary Completion: December 4, 2018
• Study Completion: December 10, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

TU (1)