ClonidineNCT06507410
Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy
A study testing Propofol and Propofol combined with clonidine in people with Clonidine and Propofol, run by Tanta University at 1 site in Egypt.
Trial summary
The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Propofol and Propofol combined with clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2024to 1 Sep 2024
- 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
- Age 18-65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Patients undergoing colonoscopy.
Who cannot join
- Patients had recent history of colonoscopy.
- Previous colonic resection.
- Severe heart failure (ejection fraction < 30%).
- Known history of hypersensitivity to propofol or clonidine and any need for anesthetic drug administration other than the study protocol.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Rabab M Mohamed, MD, 00201069122935, rabmoh_30@outlook.com
About this study
The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy.
Read the detailed description
Colonoscopy is one of the most common procedures in the world, Colonoscopy is a procedure often performed for prevention, diagnosis, and treatment of a variety of symptoms and diseases of the lower digestive tract, and sedation or anesthesia should be considered as an important tool to increase its effectiveness.
Sedation and analgesia are considered key components, as they reduce anxiety and discomfort and therefore improve the procedure tolerability and patient satisfaction, minimize risk of complications and provide better conditions for the examination.
Propofol may be used alone or in combination with opioids and/or benzodiazepines.
The use of propofol alone requires higher doses, which may lead to increased incidence of side effects. However, the risks and benefits of adding analgesic and sedative to propofol are controversial, and the selection of drugs is a crucial factor in determining the outcomes.
Clonidine apparently produces its sedative and anaesthetic-sparing effects by stimulation of centrally located alpha2 adrenoceptors. Analgesia seems to be mediated mainly by activation of alpha2 adrenoceptors in the dorsal horn of the spinal cord.
- Conditions
- Clonidine, Propofol, Sedation, Colonoscopy
- Being tested
- Propofol, Propofol combined with clonidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Continuous propofol infusion will be given with syringe pump for maintenance, with the initial rate set at 25-75 mic/kg/min IV during the first 10-15 min. To avoid administering sedatives at rates greater than clinically necessary, infusion rates will be gradually titrated to 25-50 mic/kg/min and regulated with the clinical response, with an onset of peak drug action expected to occur within 2 min.
Propofol combined with clonidineDrug
Patients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | Patients will receive induction of sedation as follow:
Continuous propofol infusion will be given with syringe pump for maintenance, with the initial rate set at 25-75 mic/kg/min IV during the first 10-15 min. To avoid administering sedatives at rates greater than clinically necessary, infusion rates will be gradually titrated to 25-50 mic/kg/min and regulated with the clinical response, with an onset of peak drug action expected to occur within 2 min. Receives: Drug: Propofol |
| Propofol combined with clonidine group | Experimental | Patients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min. Receives: Drug: Propofol combined with clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient's satisfaction level will be assessed with a Likert five-item scoring system (1 = Not at all satisfied, 2 = slightly satisfied, 3 = somewhat satisfied, 4 = very satisfied, and 5 = extremely satisfied).
Measured: 24 hours postoperatively
Secondary outcomes (3)
Heart rate
Heart rate will be recorded at 30 minutes before induction, at induction, and at the end of surgery.
Measured: Till the end of surgery
Mean arterial blood pressure
Mean arterial blood pressure will be recorded at 30 minutes before induction, at induction, and at the end of surgery.
Measured: Till the end of surgery
Side effects
Side effects such as nausea and vomiting, psychological reactions will be noted.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start20 Jul 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClonidineStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Mohamed Mohamed Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507410
- Sponsor's protocol ID
- 36264PR725/6/24
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy
- ClinicalTrials.gov ID
- NCT06507410
- Acronym / sponsor ID
- 36264PR725/6/24
- Conditions
- Clonidine, Propofol, Sedation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 Jul 2024 (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.
The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy.
Detailed description
Colonoscopy is one of the most common procedures in the world, Colonoscopy is a procedure often performed for prevention, diagnosis, and treatment of a variety of symptoms and diseases of the lower digestive tract, and sedation or anesthesia should be considered as an important tool to increase its effectiveness.
Sedation and analgesia are considered key components, as they reduce anxiety and discomfort and therefore improve the procedure tolerability and patient satisfaction, minimize risk of complications and provide better conditions for the examination.
Propofol may be used alone or in combination with opioids and/or benzodiazepines.
The use of propofol alone requires higher doses, which may lead to increased incidence of side effects. However, the risks and benefits of adding analgesic and sedative to propofol are controversial, and the selection of drugs is a crucial factor in determining the outcomes.
Clonidine apparently produces its sedative and anaesthetic-sparing effects by stimulation of centrally located alpha2 adrenoceptors. Analgesia seems to be mediated mainly by activation of alpha2 adrenoceptors in the dorsal horn of the spinal cord.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: PropofolPatients will receive induction of sedation as follow: Continuous propofol infusion will be given with syringe pump for maintenance, with the initial rate set at 25-75 mic/kg/min IV during the first 10-15 min. To avoid administering sedatives at rates greater than clinically necessary, infusion rates will be gradually titrated to 25-50 mic/kg/min and regulated with the clinical response, with an onset of peak drug action expected to occur within 2 min. |
| Propofol combined with clonidine group | Experimental | Drug: Propofol combined with clonidinePatients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Patients undergoing colonoscopy.
Key exclusion criteria (4 listed)
- Patients had recent history of colonoscopy.
- Previous colonic resection.
- Severe heart failure (ejection fraction < 30%).
- Known history of hypersensitivity to propofol or clonidine and any need for anesthetic drug administration other than the study protocol.
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 |
|---|---|---|
| PropofolContinuous propofol infusion will be given with syringe pump for maintenance, with the initial rate set at 25-75 mic/kg/min IV during the first 10-15 min. To avoid administering sedatives at rates greater than clinically necessary, infusion rates will be gradually titrated to 25-50 mic/kg/min and regulated with the clinical response, with an onset of peak drug action expected to occur within 2 min. | Drug | Propofol group |
| Propofol combined with clonidinePatients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min. | Drug | Propofol combined with clonidine group |
Primary outcome
Patient satisfaction
Time frame: 24 hours postoperatively
Patient's satisfaction level will be assessed with a Likert five-item scoring system (1 = Not at all satisfied, 2 = slightly satisfied, 3 = somewhat satisfied, 4 = very satisfied, and 5 = extremely satisfied).
3 secondary outcomes
Heart rate
Time frame: Till the end of surgery
Mean arterial blood pressure
Time frame: Till the end of surgery
Side effects
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Propofol combined with clonidine in people with Clonidine and Propofol, run by Tanta 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabab M Mohamed, MD (00201069122935, rabmoh_30@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 24 hours postoperatively). 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 23 Jul 2024.