Conscious SedationPhase 2NCT03925779
Conscious Sedation for Outpatient Colonoscopy
A Phase 2 study testing Dexmedetomidine, Propofol and Remifentanil in people with Conscious Sedation, run by Menoufia University at 1 site in Egypt.
Trial summary
Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Dexmedetomidine, Propofol and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2019to 5 Jan 2021
- Phase
- Phase 2
- 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
- ASA I or II physical status
- 18-65 years
- Scheduled for elective colonoscopy
Who cannot join
- History of allergy to any of the study drugs
- Alcohol or drug abuse.
- Second and third-degree heart block.
- Morbid obesity.
- Pregnant and lactating women.
- Psychiatric disorders.
- Severe cardiac, respiratory, renal, and liver diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.
Read the detailed description
Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.
- Conditions
- Conscious Sedation
- Being tested
- Dexmedetomidine, Propofol, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called dexmedetomidine infusion
dexmedetomidine sedation
PropofolDrug
Also called propofol infusion
propofol sedation
RemifentanilDrug
Also called Remifentanil infusion
Remifentanil sedation
| Study group | Role | What they receive |
|---|---|---|
| (Dexmedetomidine)Dex group | Active comparator | The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure Receives: Drug: Dexmedetomidine |
| Propofol-Remifentanil (P-R) group | Active comparator | Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. Receives: Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation
Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.
Measured: Perioperative
Secondary outcomes (6)
Mean arterial blood pressure
Mean arterial blood pressure in mmHg
Measured: Perioperative
Heart rate
Heart rate in beats/minutes
Measured: Perioperative
Oxygen saturation
Arterial oxygen saturation as a percentage of the total haemoglobin.
Measured: Perioperative
Hypotension
Number of patients with hypotension
Measured: Perioperative
Bradycardia
Number of patients with bradycardia
Measured: Perioperative
Analgesia
Measured by visual analogue scale [from 0 "no pain" to 10 "worst imaginable pain"]
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start15 Jun 2019
- Primary completion31 Dec 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- More trials run by Menoufia 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, MD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925779
- Sponsor's protocol ID
- 2019/3/15/9
- Status last verified
- Jan 2021
- First submitted
- 21 Apr 2019
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
- ClinicalTrials.gov ID
- NCT03925779
- Acronym / sponsor ID
- 2019/3/15/9
- Conditions
- Conscious Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 24 Apr 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.
Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.
Detailed description
Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Dexmedetomidine)Dex group | Active comparator | Drug: DexmedetomidineThe patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure |
| Propofol-Remifentanil (P-R) group | Active comparator | Drug: Propofol, Drug: RemifentanilPropofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II physical status
- 18-65 years
- Scheduled for elective colonoscopy
Key exclusion criteria (7 listed)
- History of allergy to any of the study drugs
- Alcohol or drug abuse.
- Second and third-degree heart block.
- Morbid obesity.
- Pregnant and lactating 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 |
|---|---|---|
| DexmedetomidineAlso: dexmedetomidine infusiondexmedetomidine sedation | Drug | (Dexmedetomidine)Dex group |
| PropofolAlso: propofol infusionpropofol sedation | Drug | Propofol-Remifentanil (P-R) group |
| RemifentanilAlso: Remifentanil infusionRemifentanil sedation | Drug | Propofol-Remifentanil (P-R) group |
Primary outcome
Sedation
Time frame: Perioperative
Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.
6 secondary outcomes
Mean arterial blood pressure
Time frame: Perioperative
Heart rate
Time frame: Perioperative
Oxygen saturation
Time frame: Perioperative
Hypotension
Time frame: Perioperative
Bradycardia
Time frame: Perioperative
Analgesia
Time frame: Perioperative
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 8 Jan 2021.
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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.
Abd-Elazeem A Elbakry, MD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine, Propofol and Remifentanil in people with Conscious Sedation, run by Menoufia University at 1 site in Egypt.
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 7 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 8 Jan 2021. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sedation (time frame: Perioperative). 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 8 Jan 2021.