Sedation in ERCPNCT06409104
Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP
A study testing Propofol and Dexmedetomidine in people with Sedation in ERCP, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Sedation in ERCP
- What is being tested?
- Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Feb 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age starting from 21 to 60 years.
- Genders eligible for study: males and females
- ASA II-III
- Undergoing ERCP
- 18.5 to 30 kg/m2
Who cannot join
- Patient refusal
- Known allergy to drugs used in the study.
- Use of any anti-coagulants
- Neurological disorders
- Advanced liver or kidney disease
- Patient with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography: Randomized Single Blinded Controlled Study
The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.
Read the detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) plays a crucial role in the diagnosis and treatment of pancreaticobiliary pathologies, and its use has increased in recent years. The procedure lasts from 30 to 60 position. Patients usually cannot tolerate the procedure because of pain, uncomfortable position, fear, and nausea without adequate sedation; therefore, ERCP is generally performed under moderate to deep sedation or even GA. ERCP under general anesthesia has several limitations. The procedure is often prolonged due to extra time required for patient preparation, induction of anesthesia, tracheal intubation, and recovery. In addition, the cost per procedure is higher. Deep sedation, on the other hand, is an alternative that is used by specific centers under anesthesiologist supervision instead of general anesthesia. Deep sedation has the advantage of offering the extra time required for general anesthesia and better procedure conditions in relation to conscious sedation.
Propofol is a popular drug that is frequently used in day surgery because of its early onset activity, short duration of action, and the fact that the patient regains normal mental functions only minutes after intravenous application. However, an increased dose of propofol may cause undesirable side effects such as hypoxia which is a common occurrence during upper GI endoscopy under sedation with propofol prolonged hypoxia is the most common cause of cardiac arrhythmia and coronary ischemia .Also, propofol lacks adequate analgesic effects to inhibit visceral traction, pain other side effects of propofol include hypotension and apnea.
In recent years, dexmedetomidine has been used as an alternative to Propofol in conscious sedation applications. Because it provides sedation and analgesia but does not cause respiratory depression, dexmedetomidine is considered a suitable drug for operations that are performed under local anesthesia.
According to authors best knowledge, there are no enough studies comparing both drugs in patients undergoing ERCP
Aim of the work The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.
Objectives:
- To compare the hemodynamic profile of dexmedetomidine and Propofol during sedation in patients undergoing ERCP.
- To study both agents effect on respiratory complications.
- To demonstrate the effect of both drugs on cognitive functions.
- To assess the effect of both drugs on the duration of the procedure and the number of interruptions.
Hypothesis:
The investigators hypothesize that dexmedetomidine will provide better sedation and analgesia with fewer side effects when compared to propofol in patients undergoing ERCP.
- Conditions
- Sedation in ERCP
- Being tested
- Propofol, Dexmedetomidine
- Keywords
- ERCP, Endoscopic, cancer, sedation, propofol, Dexmedetomidine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
will receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion
DexmedetomidineDrug
will receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | will receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion . Receives: Drug: Propofol |
| Dexmedetomidine | Active comparator | will receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bispectral Index sedation Score
>90 indicates an awake patient; 71-90, mild to moderate sedation; 61-70, deep sedation; and 40-60, general anesthesia
Measured: intraoperative
Secondary outcomes (5)
Change in heart rate during procedure
Change in heart rate during procedure
Measured: intraoperative
Change in MAP
Change in MAP during procedure
Measured: intraoperative
Pain during procedure according to Facial Pain Rating Scale
Pain during procedure according to Facial Pain Rating Scale (FPS;0 no pain-10 maximum pain)
Measured: first 2hours postoperative
Duration to recovery after the end of procedure
Duration to recovery after the end of procedure
Measured: first 2hours postoperative
Total doses of both agents used
Total doses of Propofol or Dexmedetomidine used
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Sep 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation in ERCPStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * To compare hemodynamic profile of dexmedetomidine and Propfol during sedation in patients undergoing ERCP. * To study both agents effect on respiratory complications. * To demonstrate the effect of both drugs on cognitive functions. * To assess the effect of both drugs on duration of procedure and number of interruptions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409104
- Sponsor's protocol ID
- MS-211-2023
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after publication
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography: Randomized Single Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT06409104
- Acronym / sponsor ID
- MS-211-2023
- Conditions
- Sedation in ERCP
- Keywords
- ERCP, Endoscopic, cancer, sedation, propofol, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 10 May 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 aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) plays a crucial role in the diagnosis and treatment of pancreaticobiliary pathologies, and its use has increased in recent years. The procedure lasts from 30 to 60 position. Patients usually cannot tolerate the procedure because of pain, uncomfortable position, fear, and nausea without adequate sedation; therefore, ERCP is generally performed under moderate to deep sedation or even GA. ERCP under general anesthesia has several limitations. The procedure is often prolonged due to extra time required for patient preparation, induction of anesthesia, tracheal intubation, and recovery. In addition, the cost per procedure is higher. Deep sedation, on the other hand, is an alternative that is used by specific centers under anesthesiologist supervision instead of general anesthesia. Deep sedation has the advantage of offering the extra time required for general anesthesia and better procedure conditions in relation to conscious sedation.
Propofol is a popular drug that is frequently used in day surgery because of its early onset activity, short duration of action, and the fact that the patient regains normal mental functions only minutes after intravenous application. However, an increased dose of propofol may cause undesirable side effects such as hypoxia which is a common occurrence during upper GI endoscopy under sedation with propofol prolonged hypoxia is the most common cause of cardiac arrhythmia and coronary ischemia .Also, propofol lacks adequate analgesic effects to inhibit visceral traction, pain other side effects of propofol include hypotension and apnea.
In recent years, dexmedetomidine has been used as an alternative to Propofol in conscious sedation applications. Because it provides sedation and analgesia but does not cause respiratory depression, dexmedetomidine is considered a suitable drug for operations that are performed under local anesthesia.
According to authors best knowledge, there are no enough studies comparing both drugs in patients undergoing ERCP
Aim of the work The aim of this study is to compare the efficacy and safety of propofol and dexmedetomidine during ERCP regarding hemodynamic, respiratory, sedative and cognitive functions.
Objectives:
- To compare the hemodynamic profile of dexmedetomidine and Propofol during sedation in patients undergoing ERCP.
- To study both agents effect on respiratory complications.
- To demonstrate the effect of both drugs on cognitive functions.
- To assess the effect of both drugs on the duration of the procedure and the number of interruptions.
Hypothesis:
The investigators hypothesize that dexmedetomidine will provide better sedation and analgesia with fewer side effects when compared to propofol in patients undergoing ERCP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- * To compare hemodynamic profile of dexmedetomidine and Propfol during sedation in patients undergoing ERCP. * To study both agents effect on respiratory complications. * To demonstrate the effect of both drugs on cognitive functions. * To assess the effect of both drugs on duration of procedure and number of interruptions.
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofolwill receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion . |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidinewill receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age starting from 21 to 60 years.
- Genders eligible for study: males and females
- ASA II-III
- Undergoing ERCP
- 18.5 to 30 kg/m2
Key exclusion criteria (6 listed)
- Patient refusal
- Known allergy to drugs used in the study.
- Use of any anti-coagulants
- Neurological disorders
- Advanced liver or kidney disease
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 |
|---|---|---|
| Propofolwill receive 1-2 mgkg-1 propofol injection over 30s followed by of propofol a 0.05 to 0.1 mg /kg/min infusion | Drug | Propofol |
| Dexmedetomidinewill receive dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by a 0.2-0.7-μg/kg/h infusion. | Drug | Dexmedetomidine |
Primary outcome
Bispectral Index sedation Score
Time frame: intraoperative
>90 indicates an awake patient; 71-90, mild to moderate sedation; 61-70, deep sedation; and 40-60, general anesthesia
5 secondary outcomes
Change in heart rate during procedure
Time frame: intraoperative
Change in MAP
Time frame: intraoperative
Pain during procedure according to Facial Pain Rating Scale
Time frame: first 2hours postoperative
Duration to recovery after the end of procedure
Time frame: first 2hours postoperative
Total doses of both agents used
Time frame: intraoperative
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 14 May 2024.
- Individual participant dataSharing planned: Undecided. after publication
Related trials for Sedation in ERCP
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Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
Anesthesia, Sedation
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Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP
Biliary Tract Diseases, Procedural Sedation and Analgesia
Not yet recruitingObservational study
Effect of Patient Anxiety Level Prior to Undergoing ERCP and Procedure Tolerability and Outcomes.
Anxiety, Biliary and Pancreatic Diseases
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Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
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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 study testing Propofol and Dexmedetomidine in people with Sedation in ERCP, run by National Cancer Institute, Egypt 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 5 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 14 May 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?
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?
Bispectral Index sedation Score (time frame: intraoperative). 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 14 May 2024.