AnalgesiaNCT04029831
Comparison of Different Ratio of Ketofol (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
A study testing Propofol and Ketamine Mixture (Ketofol) in people with Analgesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Propofol and Ketamine Mixture (Ketofol)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2017to 1 Jun 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having ERCP procedures using sedatives
- ASA (American Society of Anesthesiologist) physical status Class I to III
- Body mass index (BMI) of 18-30 kg/m2
- Willing to participate in the study
Who cannot join
- Patients with a history of allergic reaction to medications used in the study
- Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction
- Patients with unstable hemodynamic
- Patients with psychiatric medications
- Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women
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: Comparing the Effect of Different Ratio of Propofol-Ketamine Mixture (Ketofol) (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP
Read the detailed description
Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP
- Conditions
- Analgesia
- Being tested
- Propofol and Ketamine Mixture (Ketofol)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol and Ketamine Mixture (Ketofol)Drug
Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1
| Study group | Role | What they receive |
|---|---|---|
| K61 | Experimental | Patients in K61 group received propofol and ketamine in a ratio of 6:1. The 6:1 ketofol mixture was made by mixing 30 mL of 1% propofol (10 mg/mL) and 1 mL of ketamine (50 mg/ml), then 19 mL of 0.9% NaCl was added until the volume of the mixture was 50 mL. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun). Receives: Drug: Propofol and Ketamine Mixture (Ketofol) |
| K41 | Experimental | Patients in K41 group received propofol and ketamine in a ratio of 4:1. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun). Receives: Drug: Propofol and Ketamine Mixture (Ketofol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Propofol Usage
Level of propofol needed during the procedure
Measured: 1 hour
Secondary outcomes (1)
Recovery Time
Time needed to recover after the procedure
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Mar 2017
- Primary completion1 May 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhrie Sugiarto, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029831
- Sponsor's protocol ID
- IndonesiaUAnes038
- Status last verified
- Oct 2019
- First submitted
- 19 Jul 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coulter FL, Hannam JA, Anderson BJ. Ketofol dosing simulations for procedural sedation. Pediatr Emerg Care. 2014 Sep;30(9):621-30. doi: 10.1097/PEC.0000000000000222.
PubMed 25162687Bahrami Gorji F, Amri P, Shokri J, Alereza H, Bijani A. Sedative and Analgesic Effects of Propofol-Fentanyl Versus Propofol-Ketamine During Endoscopic Retrograde Cholangiopancreatography: A Double-Blind Randomized Clinical Trial. Anesth Pain Med. 2016 Aug 22;6(5):e39835. doi: 10.5812/aapm.39835. eCollection 2016 Oct.
PubMed 27853681
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Different Ratio of Propofol-Ketamine Mixture (Ketofol) (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT04029831
- Acronym / sponsor ID
- IndonesiaUAnes038
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 23 Jul 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.
Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP
Detailed description
Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K61 | Experimental | Drug: Propofol and Ketamine Mixture (Ketofol)Patients in K61 group received propofol and ketamine in a ratio of 6:1. The 6:1 ketofol mixture was made by mixing 30 mL of 1% propofol (10 mg/mL) and 1 mL of ketamine (50 mg/ml), then 19 mL of 0.9% NaCl was added until the volume of the mixture was 50 mL. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun). |
| K41 | Experimental | Drug: Propofol and Ketamine Mixture (Ketofol)Patients in K41 group received propofol and ketamine in a ratio of 4:1. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having ERCP procedures using sedatives
- ASA (American Society of Anesthesiologist) physical status Class I to III
- Body mass index (BMI) of 18-30 kg/m2
- Willing to participate in the study
Key exclusion criteria (5 listed)
- Patients with a history of allergic reaction to medications used in the study
- Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction
- Patients with unstable hemodynamic
- Patients with psychiatric medications
- Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women
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 |
|---|---|---|
| Propofol and Ketamine Mixture (Ketofol)Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1 | Drug | K41, K61 |
Primary outcome
Level of Propofol Usage
Time frame: 1 hour
Level of propofol needed during the procedure
1 secondary outcome
Recovery Time
Time frame: 15 minutes
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 23 Oct 2019.
- Results publication: PubMed 25162687Coulter FL, Hannam JA, Anderson BJ. Ketofol dosing simulations for procedural sedation. Pediatr Emerg Care. 2014 Sep;30(9):621-30. doi: 10.1097/PEC.0000000000000222.
- Results publication: PubMed 27853681Bahrami Gorji F, Amri P, Shokri J, Alereza H, Bijani A. Sedative and Analgesic Effects of Propofol-Fentanyl Versus Propofol-Ketamine During Endoscopic Retrograde Cholangiopancreatography: A Double-Blind Randomized Clinical Trial. Anesth Pain Med. 2016 Aug 22;6(5):e39835. doi: 10.5812/aapm.39835. eCollection 2016 Oct.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Ketamine Mixture (Ketofol) in people with Analgesia, 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 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: finished, as of the sponsor's last update on 23 Oct 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. 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?
Level of Propofol Usage (time frame: 1 hour). 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 NCT04029831, which also lists 2 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 23 Oct 2019.