ERCPERCPNCT04167592
Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP
A study testing Benzydamine Hydrochloride 0.15% Oral Rinse and Water in people with ERCP, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
It was a study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ERCP
- What is being tested?
- Benzydamine Hydrochloride 0.15% Oral Rinse and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2018to 1 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing ERCP
- ASA I-III
- BMI 18-30 kg/m2
Who cannot join
- allergic to propofol
- contraindicated to propofol
- had throat wound or laceration
- received analgesics or steroid in 24 hours priorly
- unstable during sedation
- procedure longer than 90 minutes
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Effectivity of Benzydamine Hydrochloride Gargle to Reduce Propofol Consumption in Endoscopic Retrograde Cholangiopancreatography Procedure
It was a study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
Read the detailed description
The study was approved by Ethics Committee of Indonesia University. It was a single-blind randomized clinical trial at Cipto Mangunkusumo Hospital - Jakarta during August to September 2018. 72 subjects were recruited and randomly assigned into 2 groups. Patients in group B were given 0.15% mouthwash with benzydamine hydrochloride prior to procedure while patients in group C were given mouthwash with 15 ml of water. Cumulative propofol consumption per minute per kg body weight, and incidence of postoperative sore throat were measured for each group.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzydamine Hydrochloride 0.15% Oral RinseDrug
Benzydamine Hydrochloride 0.15% Oral Rinse was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
WaterDrug
Water was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
| Study group | Role | What they receive |
|---|---|---|
| Benzydamine Hydrochloride Group | Active comparator | Subjects who were allocated in benzydamine group would gargle with 15 of ml benzydamine hydrochloride 0.15% before sedation started. Receives: Drug: Benzydamine Hydrochloride 0.15% Oral Rinse |
| Control Group | Placebo comparator | Subjects who were allocated in control group would gargle with 15 ml of water before sedation started. Receives: Drug: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Propofol Consumption
About 1 mg/kg Propofol was initially administered to sedate the subjects. If the subject's RSS (Ramsay Sedation Scale) rose, 0.3 mg/kg was additionally given. The amount of propofol used, as in mg/kg, during the ERCP procedure was recorded.
Measured: 90 minutes
Incidence of Sore Throat
Sore throat incidence after ERCP procedure was recorded
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Aug 2018
- Primary completion1 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ERCPStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhrie Sugiarto, Universitas Indonesia
- Investigators
- Adhrie Sugiarto, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167592
- Sponsor's protocol ID
- IndonesiaUAnes041
- Acronym
- ERCP
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463.
PubMed 23382625Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29.
PubMed 26825844Kati I, Tekin M, Silay E, Huseyinoglu UA, Yildiz H. Does benzydamine hydrochloride applied preemptively reduce sore throat due to laryngeal mask airway? Anesth Analg. 2004 Sep;99(3):710-712. doi: 10.1213/01.ANE.0000133142.52961.8D.
PubMed 15333399Sugiarto A, Kapuangan C, Tantri AR, Chrisnata V. Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial. BMC Anesthesiol. 2020 May 23;20(1):123. doi: 10.1186/s12871-020-00996-x.
PubMed 32446304
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Benzydamine Hydrochloride Gargle to Reduce Propofol Consumption in Endoscopic Retrograde Cholangiopancreatography Procedure
- ClinicalTrials.gov ID
- NCT04167592
- Acronym / sponsor ID
- ERCP / IndonesiaUAnes041
- Conditions
- ERCP
- Keywords
- propofol, benzydamine hydrochloride, sore throat, Endoscopic Retrograde Cholangiopancreatography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 19 Nov 2019 (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.
It was a study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
Detailed description
The study was approved by Ethics Committee of Indonesia University. It was a single-blind randomized clinical trial at Cipto Mangunkusumo Hospital - Jakarta during August to September 2018. 72 subjects were recruited and randomly assigned into 2 groups. Patients in group B were given 0.15% mouthwash with benzydamine hydrochloride prior to procedure while patients in group C were given mouthwash with 15 ml of water. Cumulative propofol consumption per minute per kg body weight, and incidence of postoperative sore throat were measured for each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzydamine Hydrochloride Group | Active comparator | Drug: Benzydamine Hydrochloride 0.15% Oral RinseSubjects who were allocated in benzydamine group would gargle with 15 of ml benzydamine hydrochloride 0.15% before sedation started. |
| Control Group | Placebo comparator | Drug: WaterSubjects who were allocated in control group would gargle with 15 ml of water before sedation started. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing ERCP
- ASA I-III
- BMI 18-30 kg/m2
Key exclusion criteria (6 listed)
- allergic to propofol
- contraindicated to propofol
- had throat wound or laceration
- received analgesics or steroid in 24 hours priorly
- unstable during sedation
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 |
|---|---|---|
| Benzydamine Hydrochloride 0.15% Oral RinseBenzydamine Hydrochloride 0.15% Oral Rinse was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure. | Drug | Benzydamine Hydrochloride Group |
| WaterWater was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure. | Drug | Control Group |
Primary outcome
Cumulative Propofol Consumption
Time frame: 90 minutes
About 1 mg/kg Propofol was initially administered to sedate the subjects. If the subject's RSS (Ramsay Sedation Scale) rose, 0.3 mg/kg was additionally given. The amount of propofol used, as in mg/kg, during the ERCP procedure was recorded.
Incidence of Sore Throat
Time frame: 4 hours
Sore throat incidence after ERCP procedure was recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 23382625Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463.
- Background: PubMed 26825844Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29.
- Background: PubMed 15333399Kati I, Tekin M, Silay E, Huseyinoglu UA, Yildiz H. Does benzydamine hydrochloride applied preemptively reduce sore throat due to laryngeal mask airway? Anesth Analg. 2004 Sep;99(3):710-712. doi: 10.1213/01.ANE.0000133142.52961.8D.
- Derived from this study: PubMed 32446304Sugiarto A, Kapuangan C, Tantri AR, Chrisnata V. Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial. BMC Anesthesiol. 2020 May 23;20(1):123. doi: 10.1186/s12871-020-00996-x.
- Individual participant dataSharing planned: No
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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.
Adhrie Sugiarto, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benzydamine Hydrochloride 0.15% Oral Rinse and Water in people with ERCP, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 19 Nov 2019. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Propofol Consumption (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167592, which also lists 4 linked publications.
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 19 Nov 2019.