Deep SedationsPhase 4NCT06763705
Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy
A Phase 4 study testing Midazolam, Propofol and Fentanyl in people with Deep Sedations and Conscious Sedation, run by Qassim Health Cluster at 1 site in Saudi Arabia.
Trial summary
This is a randomized, double-blinded, prospective study which will be conducted at the Department of Gastroenterology, King Saud Hospital, Unaizah, Qassim, Saudi Arabia. This study aims to compare safety and efficacy of different types of sedation medications for elective colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Deep Sedations, Conscious Sedation, Colonoscopy
- What is being tested?
- Midazolam, Propofol and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jun 2025to 14 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years
- Both Genders
- Indication of colonoscopy procedure without advanced intervention
- American Society of Anesthesiologists (ASA) physical status I or II
- Competent to give informed consent
Who cannot join
- Personal history of allergic reaction or other contra-indications to midazolam, propofol or fentanyl
- Age below 18 or above 60 years
- Chronic use of benzodiazepines
- ASA physical status III or above
- Pregnancy
- History of smoking or alcohol abuse
- Body mass index > 35 kg/m2
- History of airway obstruction or difficult intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study
This is a randomized, double-blinded, prospective study which will be conducted at the Department of Gastroenterology, King Saud Hospital, Unaizah, Qassim, Saudi Arabia. This study aims to compare safety and efficacy of different types of sedation medications for elective colonoscopy. Colonoscopy is a procedure to examine and visualize the colon by a fiberoptic tube called colonoscope. Sedation helps one to relax to avoid feel any discomfort or pain during the procedure.
Read the detailed description
The study will involve 157 patients who meet the inclusion criteria and are scheduled for elective colonoscopy. Sample size is calculated by ANOVA F test. Participants will be randomly assigned into three groups using computer-based randomization. Group I will receive intravenous midazolam + fentanyl, Group II will receive propofol only, and Group III will receive fentanyl + propofol. Dosages will be titrated as needed during the procedure, with sedation administered by trained nurses/doctors under the supervision of an anesthesiologist to ensure patient safety. Experienced endoscopists will perform the procedures, and all participants will undergo a pre-procedure evaluation, including medical history, physical examination, and assessment of allergies, comorbidities, and ASA classification. Data on patient demographics, procedure details, and sedative dosages will be collected, alongside monitoring of vital signs, oxygen saturation, and blood pressure before, during, and after the procedure.
The primary outcomes for the study include the degree of sedation, onset of sedation, patient satisfaction, and procedure completion rate. The degree of sedation will be assessed using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, while the onset of sedation will be defined as the time it takes for the patient to show drowsiness and reduced responsiveness. Secondary outcomes include adverse events, recovery time, and endoscopist satisfaction. Adverse events, such as hypotension, tachycardia, bradycardia, and hypoxia, will be recorded using pre-defined criteria for each. Recovery will be assessed every 10 minutes post-procedure using the Aldrete score, with a score of 10 indicating full recovery, after which patients can be discharged. Both patient and endoscopist satisfaction will be measured on a scale of 0 to 5 using Likert scale. This comprehensive approach aims to determine the efficacy, safety, and patient/endoscopist experience associated with the three sedative regimens during colonoscopy
- Conditions
- Deep Sedations, Conscious Sedation, Colonoscopy
- Keywords
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
It will not be used alone but in combination with Fentanyl in the Midazolam + Fentanyl group.
PropofolDrug
It will used alone in Propofol group and in combination with Fentanyl in the Propofol + Fentanyl group.
FentanylDrug
Fentanyl will not be used in isolation but will be used in combination with either Midazolam or Propofol in Midazolam + Fentanyl group and Propofol + Fentanyl group, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam + Fentanyl | Experimental | Midazolam AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Midazolam: Initial dose 0.5-1 mg. Additional doses: 1 mg every 2-3 min depending sedation level, maximum dose: 6 mg. till completion of the colonoscopy procedure Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug Receives: Drug: Midazolam; Drug: Fentanyl |
| Propofol | Experimental | Propofol Before start of colonoscopy procedure patient will be sedated with propofol in this group. Dose:induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. Maximum total dose of 200 mg. Till completion of the colonoscopy Receives: Drug: Propofol |
| Propofol +Fentanyl | Experimental | Propofol AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Propofol: Induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. maximum total dose of 200 mg. Till completion of the colonoscopy procedure.
Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug. Till completion of the colonoscopy procedure Receives: Drug: Propofol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of sedation
The degree of sedation shows the depth of sedation. It will be measured by the Observer's assessment of alertness/sedation scale with a minimum and maximum value of 1 and 5 reflecting depth of sedation. Where score 1 means deeply sedated while score 5 means fully awake. Higher scores means not enough sedation.
Measured: every 3 minutes till the end of procedure
Onset of sedation
Onset of sedation means how rapidly patient is sedated after giving the sedative medication. if after 20 minutes, patient not sedated then it will be considered failed to sedate.
Measured: It will be measured every 1 minute till 20 minutes.
Adverse events and complication
Adverse events are any unintended or undesirable clinical occurrences that arise during or after a medical procedure, treatment, or intervention. These events may be related to the procedure itself, the medications administered. These may include hypotension, bradycardia, tachycardia, hypoxia, oversedation leading to respiratory suppression
Measured: Monitored continuously during procedure and post procedure for 2 hours and then up to 48 hours after discharge on telephone
Secondary outcomes (2)
Patient's satisfaction with the procedure
It reflects patient's overall satisfaction about the colonoscopy procedure under given sedation. It will be assessed on Likert scale with minimum and maximum values of 1 to 5. On the Linkert scale 5 is maximum satisfaction and 1 is the least.
Measured: 2 hours from the start of the procedure.
procedure completion rate
The colonoscopy procedure will be considered successful if the endoscopist examines the colon from the rectum to the cecum. it will be done at 1 hour.The procedure completion rate, representing the percentage of successful procedures, will be calculated six months after collecting all data from the study.
Measured: Decision for procedure completion successfully or not will be at 1 hour. Procedure completion rate at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start15 Jun 2025
- Primary completion14 Dec 2025
- Study completion14 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep SedationsStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, double-blinded study 3 arms study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim Health Cluster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Saud Alsulaimi, Qassim Health Cluster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763705
- Sponsor's protocol ID
- 607/45/15284
- Status last verified
- Jul 2025
- First submitted
- 10 Dec 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study
- ClinicalTrials.gov ID
- NCT06763705
- Acronym / sponsor ID
- 607/45/15284
- Conditions
- Deep Sedations, Conscious Sedation, Colonoscopy
- Keywords
- colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Qassim Health ClusterUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 14 Dec 2025 (actual)
- Study completion
- 14 Dec 2025 (actual)
- First posted
- 8 Jan 2025 (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.
This is a randomized, double-blinded, prospective study which will be conducted at the Department of Gastroenterology, King Saud Hospital, Unaizah, Qassim, Saudi Arabia. This study aims to compare safety and efficacy of different types of sedation medications for elective colonoscopy. Colonoscopy is a procedure to examine and visualize the colon by a fiberoptic tube called colonoscope. Sedation helps one to relax to avoid feel any discomfort or pain during the procedure.
Detailed description
The study will involve 157 patients who meet the inclusion criteria and are scheduled for elective colonoscopy. Sample size is calculated by ANOVA F test. Participants will be randomly assigned into three groups using computer-based randomization. Group I will receive intravenous midazolam + fentanyl, Group II will receive propofol only, and Group III will receive fentanyl + propofol. Dosages will be titrated as needed during the procedure, with sedation administered by trained nurses/doctors under the supervision of an anesthesiologist to ensure patient safety. Experienced endoscopists will perform the procedures, and all participants will undergo a pre-procedure evaluation, including medical history, physical examination, and assessment of allergies, comorbidities, and ASA classification. Data on patient demographics, procedure details, and sedative dosages will be collected, alongside monitoring of vital signs, oxygen saturation, and blood pressure before, during, and after the procedure.
The primary outcomes for the study include the degree of sedation, onset of sedation, patient satisfaction, and procedure completion rate. The degree of sedation will be assessed using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, while the onset of sedation will be defined as the time it takes for the patient to show drowsiness and reduced responsiveness. Secondary outcomes include adverse events, recovery time, and endoscopist satisfaction. Adverse events, such as hypotension, tachycardia, bradycardia, and hypoxia, will be recorded using pre-defined criteria for each. Recovery will be assessed every 10 minutes post-procedure using the Aldrete score, with a score of 10 indicating full recovery, after which patients can be discharged. Both patient and endoscopist satisfaction will be measured on a scale of 0 to 5 using Likert scale. This comprehensive approach aims to determine the efficacy, safety, and patient/endoscopist experience associated with the three sedative regimens during colonoscopy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- a randomized, double-blinded study 3 arms study
| Arm | Type | Receives |
|---|---|---|
| Midazolam + Fentanyl | Experimental | Drug: Midazolam, Drug: FentanylMidazolam AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Midazolam: Initial dose 0.5-1 mg. Additional doses: 1 mg every 2-3 min depending sedation level, maximum dose: 6 mg. till completion of the colonoscopy procedure Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug |
| Propofol | Experimental | Drug: PropofolPropofol Before start of colonoscopy procedure patient will be sedated with propofol in this group. Dose:induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. Maximum total dose of 200 mg. Till completion of the colonoscopy |
| Propofol +Fentanyl | Experimental | Drug: Propofol, Drug: FentanylPropofol AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Propofol: Induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. maximum total dose of 200 mg. Till completion of the colonoscopy procedure. Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug. Till completion of the colonoscopy procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-60 years
- Both Genders
- Indication of colonoscopy procedure without advanced intervention
- American Society of Anesthesiologists (ASA) physical status I or II
- Competent to give informed consent
Key exclusion criteria (8 listed)
- Personal history of allergic reaction or other contra-indications to midazolam, propofol or fentanyl
- Age below 18 or above 60 years
- Chronic use of benzodiazepines
- ASA physical status III or above
- Pregnancy
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 |
|---|---|---|
| MidazolamIt will not be used alone but in combination with Fentanyl in the Midazolam + Fentanyl group. | Drug | Midazolam + Fentanyl |
| PropofolIt will used alone in Propofol group and in combination with Fentanyl in the Propofol + Fentanyl group. | Drug | Propofol, Propofol +Fentanyl |
| FentanylFentanyl will not be used in isolation but will be used in combination with either Midazolam or Propofol in Midazolam + Fentanyl group and Propofol + Fentanyl group, respectively. | Drug | Midazolam + Fentanyl, Propofol +Fentanyl |
Primary outcome
Degree of sedation
Time frame: every 3 minutes till the end of procedure
The degree of sedation shows the depth of sedation. It will be measured by the Observer's assessment of alertness/sedation scale with a minimum and maximum value of 1 and 5 reflecting depth of sedation. Where score 1 means deeply sedated while score 5 means fully awake. Higher scores means not enough sedation.
Onset of sedation
Time frame: It will be measured every 1 minute till 20 minutes.
Onset of sedation means how rapidly patient is sedated after giving the sedative medication. if after 20 minutes, patient not sedated then it will be considered failed to sedate.
Adverse events and complication
Time frame: Monitored continuously during procedure and post procedure for 2 hours and then up to 48 hours after discharge on telephone
Adverse events are any unintended or undesirable clinical occurrences that arise during or after a medical procedure, treatment, or intervention. These events may be related to the procedure itself, the medications administered. These may include hypotension, bradycardia, tachycardia, hypoxia, oversedation leading to respiratory suppression
2 secondary outcomes
Patient's satisfaction with the procedure
Time frame: 2 hours from the start of the procedure.
procedure completion rate
Time frame: Decision for procedure completion successfully or not will be at 1 hour. Procedure completion rate at 6 months
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 Jun 2026.
- Individual participant dataSharing planned: No. IPD data will not be shared
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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 Phase 4 study testing Midazolam, Propofol and Fentanyl in people with Deep Sedations and Conscious Sedation, run by Qassim Health Cluster at 1 site in Saudi Arabia.
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: finished, as of the sponsor's last update on 8 Jun 2026. 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 Saudi Arabia. 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 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?
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?
Degree of sedation (time frame: every 3 minutes till the end of procedure). The study lists 3 primary outcomes in all. 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 Jun 2026.