ColonoscopyPhase 3NCT04686058
Sedation Techniques for Outpatient Colonoscopy
A Phase 3 study testing Propofol 10 MG/ML Injection, Midazolam injection and Pethidine Hydrochloride 50 Mg/mL Solution for Injection in people with Colonoscopy, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Propofol 10 MG/ML Injection, Midazolam injection and Pethidine Hydrochloride 50 Mg/mL Solution for Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 3
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I or II patients
- aged between 18 to 80 years
- scheduled for outpatient colonoscopy
Who cannot join
- history of or with psychiatric disease
- on psychoactive drugs
- mentally or physically unable to use the hand-held device for PCS
- previous complications from anaesthesia or sedation
- potentially difficult airway maintenance
- obstructive sleep apnoea
- pregnant
- with contraindications to the study drugs
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Pusat Perubatan Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, 56000
About this study
Official title: Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy
This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.
Read the detailed description
This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- Propofol 10 MG/ML Injection, Midazolam injection, Pethidine Hydrochloride 50 Mg/mL Solution for Injection, target controlled infusion pump, patient-controlled sedation pump
- Keywords
- TCI propofol, PCS propofol, sedation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 10 MG/ML InjectionDrug
Also called propofol
Midazolam injectionDrug
Also called midazolam
Pethidine Hydrochloride 50 Mg/mL Solution for InjectionDrug
Also called pethidine
target controlled infusion pumpDevice
Also called TCI
patient-controlled sedation pumpDevice
Also called PCS
| Study group | Role | What they receive |
|---|---|---|
| TCI propofol | Active comparator | Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale Receives: Drug: Propofol 10 MG/ML Injection; Device: target controlled infusion pump |
| PCS propofol | Active comparator | Patient-controlled sedation titrated by the patient to comfort level Receives: Drug: Propofol 10 MG/ML Injection; Device: patient-controlled sedation pump |
| midazolam and pethidine | Active comparator | Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation Receives: Drug: Midazolam injection; Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)
Recovery of patient from sedation when MOAAS 5 is achieved
Measured: From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery
Recovery time to ambulation
Recovery of patient from sedation when patient starts ambulating
Measured: From time of arrival at the recovery area after completion of colonoscopy, until the point patient starts to ambulate, assessed up to 2 hours post arrival at recovery
Recovery time to discharge
Recovery of patient from sedation when patient is deemed fit for discharge home
Measured: From time of arrival at the recovery area after completion of colonoscopy, until the point patient is deemed fit for discharge home, assessed up to 2 hours post arrival at recovery
Endoscopist satisfaction score
After completion of colonoscopy, the endoscopist graded on a scale of 1 to 10, ease of the colonoscopy/procedure (1 = very difficult, 10 = very easy), and level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
Measured: After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy
Patient satisfaction score
After completion of colonoscopy, the patient graded on a scale of 1 to 10, the level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
Measured: Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation
Patient willingness to repeat the same sedation technique
Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future
Measured: From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery
Secondary outcomes (5)
Rescue analgesic drug requirement
Requirement for rescue analgesic or sedative in addition to study drugs/sedatives, during the entire duration of colonoscopy
Measured: From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation
Total drug consumption
Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy
Measured: Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy, assessed up to 2 hours from the start of sedation
Ease of colonoscopy score
endoscopist graded on a scale of 1 to 10, ease of procedure (1 = very difficult, 10 = very easy)
Measured: during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy
Recalled events during colonoscopy
The number of recalled events during the entire duration of colonoscopy
Measured: Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery
Recalled discomfort/ pain during colonoscopy
The number of recalled events of discomfor/pain during the entire duration of colonoscopy
Measured: Recalled events of discomfort/pain retrived from the patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Md Nor, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686058
- Sponsor's protocol ID
- FF-2014-203
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Patient-controlled Sedation Versus Target-controlled Infusion in Outpatient Colonoscopy
- ClinicalTrials.gov ID
- NCT04686058
- Acronym / sponsor ID
- FF-2014-203
- Conditions
- Colonoscopy
- Keywords
- TCI propofol, PCS propofol, sedation, colonoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Dec 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 was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.
Detailed description
This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TCI propofol | Active comparator | Drug: Propofol 10 MG/ML Injection, Device: target controlled infusion pumpTarget controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale |
| PCS propofol | Active comparator | Drug: Propofol 10 MG/ML Injection, Device: patient-controlled sedation pumpPatient-controlled sedation titrated by the patient to comfort level |
| midazolam and pethidine | Active comparator | Drug: Midazolam injection, Drug: Pethidine Hydrochloride 50 Mg/mL Solution for InjectionMidazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II patients
- aged between 18 to 80 years
- scheduled for outpatient colonoscopy
Key exclusion criteria (8 listed)
- history of or with psychiatric disease
- on psychoactive drugs
- mentally or physically unable to use the hand-held device for PCS
- previous complications from anaesthesia or sedation
- potentially difficult airway maintenance
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 10 MG/ML InjectionAlso: propofol | Drug | PCS propofol, TCI propofol |
| Midazolam injectionAlso: midazolam | Drug | midazolam and pethidine |
| Pethidine Hydrochloride 50 Mg/mL Solution for InjectionAlso: pethidine | Drug | midazolam and pethidine |
| target controlled infusion pumpAlso: TCI | Device | TCI propofol |
| patient-controlled sedation pumpAlso: PCS | Device | PCS propofol |
Primary outcome
Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS)
Time frame: From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery
Recovery of patient from sedation when MOAAS 5 is achieved
Recovery time to ambulation
Time frame: From time of arrival at the recovery area after completion of colonoscopy, until the point patient starts to ambulate, assessed up to 2 hours post arrival at recovery
Recovery of patient from sedation when patient starts ambulating
Recovery time to discharge
Time frame: From time of arrival at the recovery area after completion of colonoscopy, until the point patient is deemed fit for discharge home, assessed up to 2 hours post arrival at recovery
Recovery of patient from sedation when patient is deemed fit for discharge home
Endoscopist satisfaction score
Time frame: After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy
After completion of colonoscopy, the endoscopist graded on a scale of 1 to 10, ease of the colonoscopy/procedure (1 = very difficult, 10 = very easy), and level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
Patient satisfaction score
Time frame: Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation
After completion of colonoscopy, the patient graded on a scale of 1 to 10, the level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS).
Patient willingness to repeat the same sedation technique
Time frame: From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery
Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future
5 secondary outcomes
Rescue analgesic drug requirement
Time frame: From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation
Total drug consumption
Time frame: Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy, assessed up to 2 hours from the start of sedation
Ease of colonoscopy score
Time frame: during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy
Recalled events during colonoscopy
Time frame: Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery
Recalled discomfort/ pain during colonoscopy
Time frame: Recalled events of discomfort/pain retrived from the patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery
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 28 Dec 2020.
- 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 Phase 3 study testing Propofol 10 MG/ML Injection, Midazolam injection and Pethidine Hydrochloride 50 Mg/mL Solution for Injection in people with Colonoscopy, 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 3 inclusion and 8 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 28 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS) (time frame: From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery). The study lists 6 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 Dec 2020.