ColonoscopyPhase 4NCT05689242
Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy
A Phase 4 study testing Dexmedetomidine Injection [Precedex] in people with Colonoscopy, run by Assiut University.
Trial summary
The aim of this study is to compare the sedative, analgesic effect and hemodynamic changes due to dexmedetomidine and nalbuphine during elective colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Dexmedetomidine Injection [Precedex]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2024
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is scheduled for elective colonoscopy.
- The subject is ≥ 18 years and ≤ 80 years.
- Both sexes.
- No obvious abnormalities in preoperative ECG, blood routine ,electrolytes, and other tests .
- ASA class 1-3.
Who cannot join
- Subject is known or believed to be pregnant or lactating women.
- Patients allergic to α2-adrenergic agonist or sulfa drugs
- Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers.
- Sleep apnea syndrome or difficult airway.
- Patient known to be asthmatic or recent chest infection.
- Patients that are prisoners.
- Patient refusal.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy
The aim of this study is to compare the sedative, analgesic effect and hemodynamic changes due to dexmedetomidine and nalbuphine during elective colonoscopy.
Read the detailed description
Colonoscopy can be performed for the screening of cancer, adenomas, and polyps, for the assessment of known or possible bleeding, and for the evaluation of possible causes of abdominal pain, gastrointestinal symptoms, and/or changes in bowel habits. colonoscopy is associated with discomfort and sometimes pain. At present, the commonly used methods are the intravenous injection of propofol, etomidate, ketamine, and other drugs to make the patient's unconscious. The disadvantage is that the patient cannot cooperate during the examination (e.g., for changing position), and medical staff is needed to assist in turning over the patient, if necessary. This may compress the patient's stomach and abdomen, which may cause gastric reflux and aspiration, which may cause pneumonia, with morbidity and even mortality. Nalbuphine hydrochloride is a mixed agonist-antagonist opioid with a duration of action of approximately 3-6 hours. It is chemically related to both the agonist analgesic oxymorphone and the antagonist naloxone, and acts as an antagonist at the μ receptor and as an agonist at the κ receptor, resulting in analgesia and sedation with minimal effects in the cardiovascular system. Any slight RD that occurs would be restricted by a ceiling effect. Dexmedetomidine, a new drug, is highly selective α2-adrenergic receptor agonist. It possesses hypnotic, sedative, anxiolytic, sympatholytic, and analgesic properties without producing significant respiratory depression. It also reduces both anesthetic and opioid analgesic requirements during the perioperative period. It has an impressive safety margin,and it may be suitable for conscious sedation during painful procedures.
- Conditions
- Colonoscopy
- Being tested
- Dexmedetomidine Injection [Precedex]
- Keywords
- Dexmedetomidine, nalbuphine, colonoscopy, Conscious Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
Also called nalbuphine
intravenous dexmedetomidine for group I and nalubphine for group II in colposcopy
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Receive initial loading dose of (Dexmedetomidine 1 μg/kg I.V) diluted up to 10 ml with normal saline infused over 10 min, followed by a continuous infusion of 0.2-0.8 μg/kg/h through a 50 ml syringe and an electronic infusion pump Receives: Drug: Dexmedetomidine Injection [Precedex] |
| Group II | Experimental | Receive (Nalbuphine 0.1 to 0.2 mg/kg I.V) diluted up to 10 ml with normal saline infused slowly over 10 min. Receives: Drug: Dexmedetomidine Injection [Precedex] |
What is being measured
The primary outcome is the main question the study is designed to answer.
variable is to compare the sedation effect between Nalbuphine and Dexmedetomidine.
3- Sedation score: sedation will be monitored immediately after examination, at PACU admission, and 30 min after procedure by Ramsay Sedation Scale (RSS; 1974) The RSS scores sedation at six different levels, according to how rousable the patient is.
- Patient is anxious and agitated or restless, or both.
- Patient is cooperative, oriented and tranquil.
- Patient responds to commands only.
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
- Patient exhibits no response
Measured: before the study drug administration (baseline), after the study drug administration ,Then every 5min till the examination ends,at PACU admission, and 30 min after procedure.
Secondary outcomes (1)
variables are the hemodynamic comparison, pain score assessment and adverse event among two groups.
4- Pain score: Intensity of pain will be monitored immediately after examination, at PACU admission, and 30 min after procedure by visual analogue score (VAS),The (VAS) consist of 10cm line, with to end points representing 0 (no pain) and 10 (pain as bad as it possibly be), ask the patient to rete their current level of pain by placing a mark on the line, by using a ruler to measure the distance from 0 (no pain point) to the current pain mark
Measured: before the study drug administration (baseline), after the study drug administration ,Then every 5min till the examination ends,at PACU admission, and 30 min after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OMAR ABDELAZIZ ABOELFADL, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689242
- Sponsor's protocol ID
- sedation in Colonoscopy
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ulmer BJ, Hansen JJ, Overley CA, Symms MR, Chadalawada V, Liangpunsakul S, Strahl E, Mendel AM, Rex DK. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003 Nov;1(6):425-32. doi: 10.1016/s1542-3565(03)00226-x.
PubMed 15017641Muller S, Borowics SM, Fortis EA, Stefani LC, Soares G, Maguilnik I, Breyer HP, Hidalgo MP, Caumo W. Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP. Gastrointest Endosc. 2008 Apr;67(4):651-9. doi: 10.1016/j.gie.2007.09.041. Epub 2008 Mar 4.
PubMed 18291396Kaygusuz K, Gokce G, Gursoy S, Ayan S, Mimaroglu C, Gultekin Y. A comparison of sedation with dexmedetomidine or propofol during shockwave lithotripsy: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):114-9, table of contents. doi: 10.1213/01.ane.0000296453.75494.64.
PubMed 18165564Karanth H, Murali S, Koteshwar R, Shetty V, Adappa K. Comparative Study between Propofol and Dexmedetomidine for Conscious Sedation in Patients Undergoing Outpatient Colonoscopy. Anesth Essays Res. 2018 Jan-Mar;12(1):98-102. doi: 10.4103/aer.AER_206_17.
PubMed 29628562Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
PubMed 19713256Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
PubMed 1026900Abdelrady MM, Yousef HA, Khalaf KA, Abulfadl OA, Hassanien MH. Comparative study between nalbuphine and dexmedetomidine for conscious sedation in patients undergoing colonoscopy: randomized comparative trial. BMC Anesthesiol. 2025 Nov 28;25(1):603. doi: 10.1186/s12871-025-03482-4.
PubMed 41310459
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intravenous Nalbuphine Versus Intravenous Dexmedetomidine for Conscious Sedation in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT05689242
- Acronym / sponsor ID
- sedation in Colonoscopy
- Conditions
- Colonoscopy
- Keywords
- Dexmedetomidine, nalbuphine, colonoscopy, Conscious Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Jan 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.
The aim of this study is to compare the sedative, analgesic effect and hemodynamic changes due to dexmedetomidine and nalbuphine during elective colonoscopy.
Detailed description
Colonoscopy can be performed for the screening of cancer, adenomas, and polyps, for the assessment of known or possible bleeding, and for the evaluation of possible causes of abdominal pain, gastrointestinal symptoms, and/or changes in bowel habits. colonoscopy is associated with discomfort and sometimes pain. At present, the commonly used methods are the intravenous injection of propofol, etomidate, ketamine, and other drugs to make the patient's unconscious. The disadvantage is that the patient cannot cooperate during the examination (e.g., for changing position), and medical staff is needed to assist in turning over the patient, if necessary. This may compress the patient's stomach and abdomen, which may cause gastric reflux and aspiration, which may cause pneumonia, with morbidity and even mortality. Nalbuphine hydrochloride is a mixed agonist-antagonist opioid with a duration of action of approximately 3-6 hours. It is chemically related to both the agonist analgesic oxymorphone and the antagonist naloxone, and acts as an antagonist at the μ receptor and as an agonist at the κ receptor, resulting in analgesia and sedation with minimal effects in the cardiovascular system. Any slight RD that occurs would be restricted by a ceiling effect. Dexmedetomidine, a new drug, is highly selective α2-adrenergic receptor agonist. It possesses hypnotic, sedative, anxiolytic, sympatholytic, and analgesic properties without producing significant respiratory depression. It also reduces both anesthetic and opioid analgesic requirements during the perioperative period. It has an impressive safety margin,and it may be suitable for conscious sedation during painful procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Dexmedetomidine Injection [Precedex]Receive initial loading dose of (Dexmedetomidine 1 μg/kg I.V) diluted up to 10 ml with normal saline infused over 10 min, followed by a continuous infusion of 0.2-0.8 μg/kg/h through a 50 ml syringe and an electronic infusion pump |
| Group II | Experimental | Drug: Dexmedetomidine Injection [Precedex]Receive (Nalbuphine 0.1 to 0.2 mg/kg I.V) diluted up to 10 ml with normal saline infused slowly over 10 min. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is scheduled for elective colonoscopy.
- The subject is ≥ 18 years and ≤ 80 years.
- Both sexes.
- No obvious abnormalities in preoperative ECG, blood routine ,electrolytes, and other tests .
- ASA class 1-3.
Key exclusion criteria (8 listed)
- Subject is known or believed to be pregnant or lactating women.
- Patients allergic to α2-adrenergic agonist or sulfa drugs
- Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers.
- Sleep apnea syndrome or difficult airway.
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 |
|---|---|---|
| Dexmedetomidine Injection [Precedex]Also: nalbuphineintravenous dexmedetomidine for group I and nalubphine for group II in colposcopy | Drug | Group I, Group II |
Primary outcome
variable is to compare the sedation effect between Nalbuphine and Dexmedetomidine.
Time frame: before the study drug administration (baseline), after the study drug administration ,Then every 5min till the examination ends,at PACU admission, and 30 min after procedure.
3- Sedation score: sedation will be monitored immediately after examination, at PACU admission, and 30 min after procedure by Ramsay Sedation Scale (RSS; 1974) The RSS scores sedation at six different levels, according to how rousable the patient is. 1. Patient is anxious and agitated or restless, or both. 2. Patient is cooperative, oriented and tranquil. 3. Patient responds to commands only. 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6. Patient exhibits no response
1 secondary outcome
variables are the hemodynamic comparison, pain score assessment and adverse event among two groups.
Time frame: before the study drug administration (baseline), after the study drug administration ,Then every 5min till the examination ends,at PACU admission, and 30 min after procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 15017641Ulmer BJ, Hansen JJ, Overley CA, Symms MR, Chadalawada V, Liangpunsakul S, Strahl E, Mendel AM, Rex DK. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003 Nov;1(6):425-32. doi: 10.1016/s1542-3565(03)00226-x.
- Background: PubMed 18291396Muller S, Borowics SM, Fortis EA, Stefani LC, Soares G, Maguilnik I, Breyer HP, Hidalgo MP, Caumo W. Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP. Gastrointest Endosc. 2008 Apr;67(4):651-9. doi: 10.1016/j.gie.2007.09.041. Epub 2008 Mar 4.
- Background: PubMed 18165564Kaygusuz K, Gokce G, Gursoy S, Ayan S, Mimaroglu C, Gultekin Y. A comparison of sedation with dexmedetomidine or propofol during shockwave lithotripsy: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):114-9, table of contents. doi: 10.1213/01.ane.0000296453.75494.64.
- Background: PubMed 29628562Karanth H, Murali S, Koteshwar R, Shetty V, Adappa K. Comparative Study between Propofol and Dexmedetomidine for Conscious Sedation in Patients Undergoing Outpatient Colonoscopy. Anesth Essays Res. 2018 Jan-Mar;12(1):98-102. doi: 10.4103/aer.AER_206_17.
- Background: PubMed 19713256Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
- Background: PubMed 1026900Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
- Derived from this study: PubMed 41310459Abdelrady MM, Yousef HA, Khalaf KA, Abulfadl OA, Hassanien MH. Comparative study between nalbuphine and dexmedetomidine for conscious sedation in patients undergoing colonoscopy: randomized comparative trial. BMC Anesthesiol. 2025 Nov 28;25(1):603. doi: 10.1186/s12871-025-03482-4.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine Injection [Precedex] in people with Colonoscopy, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 omar AB abulfadl, bachelor's (0021069909234, omarabulfadl1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variable is to compare the sedation effect between Nalbuphine and Dexmedetomidine. (time frame: before the study drug administration (baseline), after the study drug administration ,Then every 5min till the examination ends,at PACU admission, and 30 min after procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689242, which also lists 7 linked publications.
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 19 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.