Ketamine Adverse ReactionPhase 4NCT04490031
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
A Phase 4 study testing Ketamine Hydrochloride in people with Ketamine Adverse Reaction, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ketamine Adverse Reaction
- What is being tested?
- Ketamine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2020to 30 Apr 2021
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Malaysian citizens of who is able to give valid consent
- Patient planned for ERCP (either emergency or elective)
Who cannot join
- Known hypersensitivity towards Ketamine or Midazolam
- Patient refusal to participate or unable to give consent
- Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
- Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
- Acute myocardial infarction, acute coronary syndrome (<3 months)
- Tachyarrythmia
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- Pregnancy
- IVDU or substance abuse patient
- Patient with history of hallucination
- Child's Pugh Class C
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
University Kebangsaan Malaysia Medical center
Bandar Tun Razak, Kuala Lumpur, 56000
Zamri Zuhdi, MD, 6019 2436634, zamriz7582@gmail.com
Ian Chik, MD, 0123243404, ianchikmd@gmail.com
About this study
Official title: Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.
Read the detailed description
This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.
- Conditions
- Ketamine Adverse Reaction
- Being tested
- Ketamine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
patient in Ketamine group will be given Ketamine as sedative agent
| Study group | Role | What they receive |
|---|---|---|
| Midazolam group | No intervention | Standard sedation for ERCP in UKMMC |
| Ketamine group | Experimental | Not described Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
depth of sedation
based on Ramsay Sedation Scale, from a scale of 1-6.
- Patient is anxious and agitated or restless, or both
- Patient is co-operative, oriented, and tranquil
- Patient responds to commands only
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
- Patient exhibits no response The aim of sedation is a score of 3-4
Measured: 1 hour
completion rate
to evaluate completion rate between Ketamine and Midazolam group
Measured: 1 hour
Secondary outcomes (3)
Surgeon satisfaction score
subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10.
0- poor, 5- moderate, 10- excellent
Measured: within 4 hours after completion of ERCP
Patient satisfaction score
subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10.
0- poor, 5- moderate, 10- excellent
Measured: within 4 hours after completion of ERCP
evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms
recording the adverse events of each sedation.
- Hypotension: defined as a systolic blood pressure drop greater than 20mmHg to a value less than 90mmHg
- Hypertension: defined as a systolic blood pressure increase greater than 20mmHg or to a value more than 140mmHg
- Bradycardia: defined as heart rate less than 50 after the initiation of sedation or decrease in heart rate more than 20 beats per minute
- Tachycardia: defined as heart rate more than 100 after the initiation of sedation or increase in heart rate more than 20 beats per minute
- Hypoxia: defined by oxygen saturation less than 95%
- Respiratory rate abnormality
- Nausea, vomiting, emergence symptoms
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketamine Adverse ReactionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Chik, MD, Principal investigator, Universiti Kebangsaan Malaysia Medical CentreNorma mohamad, MD, Principal investigator, Universiti Kebangsaan Malaysia Medical CentreZamri Zuhdi, MD, Principal investigator, Universiti Kebangsaan Malaysia Medical CentreAzlanudin Azman, MD, Principal investigator, Universiti Kebangsaan Malaysia Medical CentreMuhammad Hafiz Ismail, MD, Principal investigator, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490031
- Sponsor's protocol ID
- Hukm
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT04490031
- Acronym / sponsor ID
- Hukm
- Conditions
- Ketamine Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 28 Jul 2020 (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.
This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.
Detailed description
This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used. Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria. Patients will be divided into two arms, Midazolam and Ketamine group respectively. Before the initiation of the the scope, patient would be given specified dose of sedation accordingly. All the parameters and outcome would be measured during and after the procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam group | No intervention | –Standard sedation for ERCP in UKMMC |
| Ketamine group | Experimental | Drug: Ketamine Hydrochloride |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Malaysian citizens of who is able to give valid consent
- Patient planned for ERCP (either emergency or elective)
Key exclusion criteria (10 listed)
- Known hypersensitivity towards Ketamine or Midazolam
- Patient refusal to participate or unable to give consent
- Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
- Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
- Acute myocardial infarction, acute coronary syndrome (<3 months)
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 |
|---|---|---|
| Ketamine Hydrochloridepatient in Ketamine group will be given Ketamine as sedative agent | Drug | Ketamine group |
Primary outcome
depth of sedation
Time frame: 1 hour
based on Ramsay Sedation Scale, from a scale of 1-6. 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response The aim of sedation is a score of 3-4
completion rate
Time frame: 1 hour
to evaluate completion rate between Ketamine and Midazolam group
3 secondary outcomes
Surgeon satisfaction score
Time frame: within 4 hours after completion of ERCP
Patient satisfaction score
Time frame: within 4 hours after completion of ERCP
evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Ketamine Adverse Reaction
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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.
Ian Chik, MD principal investigator
Universiti Kebangsaan Malaysia Medical Centre
Norma mohamad, MD principal investigator
Universiti Kebangsaan Malaysia Medical Centre
Zamri Zuhdi, MD principal investigator
Universiti Kebangsaan Malaysia Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine Hydrochloride in people with Ketamine Adverse Reaction, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 28 Jul 2020. 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 Malaysia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Hafiz Ismail, MBBS (6016 3354384, muhdhafizismail88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depth of sedation (time frame: 1 hour). 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?
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 28 Jul 2020.