Anxiety and FearNCT06148103
A Comparison Between Dexmedetomidine and Propofol-fentanyl Infusions for Sedation for Colonoscopy Procedures
A study testing Patients who received Dexmedetomodine and patients who received propofol-fentanyl in people with Anxiety and Fear, run by Zulekha Hospitals at 1 site in Egypt.
Trial summary
Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- Patients who received Dexmedetomodine and patients who received propofol-fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2021to 6 May 2023
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- both sexes
- 21-60 years old, with
- ASA physical status -
Who cannot join
- severe cardiovascular or respiratory disease
- (ASA grade ≥III)
- pregnancy
- allergies to the drugs being used
- known alcohol or substance abuse
- expected communication difficulties with the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sedation for Colonoscopy Procedures Using Dexmedetomidine Versus Propofol-Fentanyl Infusions: A Prospective Randomized Controlled Trial
Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.
Read the detailed description
Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.
Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.
- Conditions
- Anxiety and Fear
- Being tested
- Patients who received Dexmedetomodine, patients who received propofol-fentanyl
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who received DexmedetomodineDrug
Also called D group
1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h).
patients who received propofol-fentanylDrug
Also called PF group
Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.
| Study group | Role | What they receive |
|---|---|---|
| D group | Other | Patients who received Dexmedetomidine. The starting dose of dexmedetomidine was 1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h). Receives: Drug: Patients who received Dexmedetomodine |
| PF group | Other | Patients who received Propofol-Fentanyl infusions. Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively. Receives: Drug: patients who received propofol-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of painless sedation during colonoscopy.
The patient's ability to cooperate and perform the procedure was evaluated using a 10-point numerical rating scale (NRS).
Measured: From start of procedure to 120 minutes after end of colonoscopy
Secondary outcomes (1)
incidence of adverse events, Prevalence of adverse effects
incidence of adverse events, hemodynamic instability, failure to provide adequate sedation.
Measured: from start of procedure to 120 minutes after end of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start5 Dec 2021
- Primary completion6 May 2023
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zulekha Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- sameh H Seyam, professor, Principal investigator, Assistant professor, Anesthesiology, Intensive care and pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148103
- Sponsor's protocol ID
- 00385
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation for Colonoscopy Procedures Using Dexmedetomidine Versus Propofol-Fentanyl Infusions: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06148103
- Acronym / sponsor ID
- 00385
- Conditions
- Anxiety and Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zulekha HospitalsUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 28 Nov 2023 (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.
Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.
Detailed description
Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.
Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D group | Other | Drug: Patients who received DexmedetomodinePatients who received Dexmedetomidine. The starting dose of dexmedetomidine was 1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h). |
| PF group | Other | Drug: patients who received propofol-fentanylPatients who received Propofol-Fentanyl infusions. Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Patients who received DexmedetomodineAlso: D group1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h). | Drug | D group |
| patients who received propofol-fentanylAlso: PF groupContinued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively. | Drug | PF group |
Primary outcome
The quality of painless sedation during colonoscopy.
Time frame: From start of procedure to 120 minutes after end of colonoscopy
The patient's ability to cooperate and perform the procedure was evaluated using a 10-point numerical rating scale (NRS).
1 secondary outcome
incidence of adverse events, Prevalence of adverse effects
Time frame: from start of procedure to 120 minutes after end of colonoscopy
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 Nov 2023.
- 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.
sameh H Seyam, professor principal investigator
Assistant professor, Anesthesiology, Intensive care and pain management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients who received Dexmedetomodine and patients who received propofol-fentanyl in people with Anxiety and Fear, run by Zulekha Hospitals 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 6 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 Nov 2023. 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?
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?
The quality of painless sedation during colonoscopy. (time frame: From start of procedure to 120 minutes after end of colonoscopy). 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 Nov 2023.