AnesthesiaNCT03424356
Effects of Low Dose Neuromuscular Blocker Usage on Laryngeal Mask Application
A study testing Rocuronium Bromide, Saline Solution and Fentanyl in people with Anesthesia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Rocuronium Bromide, Saline Solution and Fentanyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients
- ASA I-II patients
- Cystoscopy patients
- patients entubated with lariyngeal mask
Who cannot join
- Female patients
- Asa III-IV patients
- Surgery duration is more than 2 hours
- Drug abusers
- Non compromising patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri, 38039
mustafa asan, md, +905059352060, mustafaasan@yahoo.com
ayse ülgey, md, +905378201751, aülgey38@gmail.com
About this study
Official title: 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.
Read the 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
- Keywords
- LMA, Rocuronium bromur, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium BromideDrug
Also called nueromusculer blocker
0.15 mg/kg rocuronium bromide
Saline SolutionDrug
Also called saline
1-2 ml saline solution
FentanylDrug
Also called narcotic analgesic
1mcg/kg for induction
PropofolDrug
Also called hypnotic agent
2-3mg/kg for anaesthetic induction
cystoscopyProcedure or surgery
Also called surgical prosedure
patients will treated with this surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline Solution; Drug: Fentanyl; Drug: Propofol; Procedure: cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire
The quality of LMA placement with or without neuromusculer drug.
Measured: up to first 60 minutes
Secondary outcomes (1)
questionnaire
after the surgery soar throat will be evaluated
Measured: up to first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start4 Jan 2017
- Primary completion4 Dec 2018 (estimated)
- Study completion10 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ulgey, TC Erciyes University
- Investigators
- ayşe ülgey, md, Study chair, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424356
- Sponsor's protocol ID
- 2017/15
- Status last verified
- Jun 2018
- First submitted
- 15 Nov 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Low Dose Neuromuscular Blocker Added to Propofol Fentanyl Combination During Lma Procedures in Cystoscopy Patients
- ClinicalTrials.gov ID
- NCT03424356
- Acronym / sponsor ID
- 2017/15
- Conditions
- Anesthesia
- Keywords
- LMA, Rocuronium bromur, propofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 4 Dec 2018 (estimated)
- Study completion
- 10 Dec 2018 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lma with rocuronium bromide | Experimental | Drug: Rocuronium Bromide, Drug: Fentanyl, Drug: Propofol, Procedure: cystoscopyIn 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. |
| lma with saline solution | Active comparator | Drug: Saline Solution, Drug: Fentanyl, Drug: Propofol, Procedure: cystoscopyIn control group, 2-3 mg/kg propofol, 1 mcg/kg fentanyl and saline(no rocuronium) will be administered during lma insertion in cystoscopy procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients
- ASA I-II patients
- Cystoscopy patients
- patients entubated with lariyngeal mask
Key exclusion criteria (5 listed)
- Female patients
- Asa III-IV patients
- Surgery duration is more than 2 hours
- Drug abusers
- Non compromising patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium BromideAlso: nueromusculer blocker0.15 mg/kg rocuronium bromide | Drug | lma with rocuronium bromide |
| Saline SolutionAlso: saline1-2 ml saline solution | Drug | lma with saline solution |
| FentanylAlso: narcotic analgesic1mcg/kg for induction | Drug | lma with rocuronium bromide, lma with saline solution |
| PropofolAlso: hypnotic agent2-3mg/kg for anaesthetic induction | Drug | lma with rocuronium bromide, lma with saline solution |
| cystoscopyAlso: surgical prosedurepatients will treated with this surgical procedure | Procedure or surgery | lma with rocuronium bromide, lma with saline solution |
Primary outcome
questionnaire
Time frame: up to first 60 minutes
The quality of LMA placement with or without neuromusculer drug.
1 secondary outcome
questionnaire
Time frame: up to first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayşe ülgey, md study chair
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium Bromide, Saline Solution and Fentanyl in people with Anesthesia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mustafa asan, md (+905059352060, mustafaasan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire (time frame: up to first 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.