Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application

June 12, 2018 updated by: Ayse Ulgey, TC Erciyes University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Rocuronium Bromide
0.15 mg/kg rocuronium bromide
Other Names:
  • nueromusculer blocker
Drug: Fentanyl
1mcg/kg for induction
Other Names:
  • narcotic analgesic
Drug: Propofol
2-3mg/kg for anaesthetic induction
Other Names:
  • hypnotic agent
Procedure: cystoscopy
patients will treated with this surgical procedure
Other Names:
  • surgical prosedure
ACTIVE_COMPARATOR: 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.
Drug: Fentanyl
1mcg/kg for induction
Other Names:
  • narcotic analgesic
Drug: Propofol
2-3mg/kg for anaesthetic induction
Other Names:
  • hypnotic agent
Procedure: cystoscopy
patients will treated with this surgical procedure
Other Names:
  • surgical prosedure
Drug: Saline Solution
1-2 ml saline solution
Other Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
questionnaire
Time Frame: up to first 60 minutes
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
Time Frame: up to first 24 hours
after the surgery soar throat will be evaluated
up to first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Study Chair: ayşe ülgey, md, TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2017

Primary Completion (ANTICIPATED)

December 4, 2018

Study Completion (ANTICIPATED)

December 10, 2018

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

January 31, 2018

First Posted (ACTUAL)

February 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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