ColonoscopyPhase 4NCT00376831
The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
A Phase 4 study testing Midazolam, Fentanyl and KETAMINE, MIDAZOLAM in people with Colonoscopy and Conscious Sedation, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure. There are various protocols and methods used to prevent discomfort and alleviate pain. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Conscious Sedation
- What is being tested?
- Midazolam, Fentanyl and KETAMINE, MIDAZOLAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Jun 2007
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent.
Who cannot join
- Hypersensitivity to benzodiazepines
- Hypersensitivity to benzyl alcohol
- Hypersensitivity to ketamine
- Hypersensitivity to opiates
- Pregnancy
- Uncontrolled hypertension
Show all 16Show fewer
- Myocardial infarct in the last 6 months
- CVA
- Chronic pulmonary disease
- Renal failure
- Chronic liver disease (CHILD B or C)
- Elevated ICP, cerebral hemorrhage or cranial SOL.
- Hypovolemic shock
- Glaucoma
- Mental illness
- Drug or alcohol addiction
Trial locations and contacts
1 site in 1 country.
About this study
Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.
There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.
Read more
This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.
The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.
The results will be compiled from objective data and patient and physician interviews.
- Conditions
- Colonoscopy, Conscious Sedation
- Being tested
- Midazolam, Fentanyl, KETAMINE, MIDAZOLAM
- Keywords
- colonoscopy, conscious sedation, midazolam, ketamine, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam, FentanylDrug
fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
KETAMINE, MIDAZOLAMDrug
Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 0 | Active comparator | fentanyl Receives: Drug: Midazolam, Fentanyl |
| 1 | Active comparator | ketamine Receives: Drug: KETAMINE, MIDAZOLAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Measured: 24 hours following colonoscopy
Secondary outcomes (3)
Sedative effect
Measured: 24 hours following colonoscopy
Patient compliance
Measured: 24 hours following colonoscopy
Side effects
Measured: 24 hours following colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- pavel krugliak, md. professor, Principal investigator, Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376831
- Sponsor's protocol ID
- SOR440806CTIL
- Status last verified
- Aug 2007
- First submitted
- 14 Sep 2006
- Last updated
- 10 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
- ClinicalTrials.gov ID
- NCT00376831
- Acronym / sponsor ID
- SOR440806CTIL
- Conditions
- Colonoscopy, Conscious Sedation
- Keywords
- colonoscopy, conscious sedation, midazolam, ketamine, fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Sep 2006 (estimated)
- 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.
Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.
There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.
This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.
The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.
The results will be compiled from objective data and patient and physician interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0 | Active comparator | Drug: Midazolam, Fentanylfentanyl |
| 1 | Active comparator | Drug: KETAMINE, MIDAZOLAMketamine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent.
Key exclusion criteria (16 listed)
- Hypersensitivity to benzodiazepines
- Hypersensitivity to benzyl alcohol
- Hypersensitivity to ketamine
- Hypersensitivity to opiates
- 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 |
|---|---|---|
| Midazolam, Fentanylfentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg | Drug | 0 |
| KETAMINE, MIDAZOLAMKetamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg | Drug | 1 |
Primary outcome
Recovery time
Time frame: 24 hours following colonoscopy
3 secondary outcomes
Sedative effect
Time frame: 24 hours following colonoscopy
Patient compliance
Time frame: 24 hours following colonoscopy
Side effects
Time frame: 24 hours following 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 10 Aug 2007.
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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.
pavel krugliak, md. professor principal investigator
Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
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, Fentanyl and KETAMINE, MIDAZOLAM in people with Colonoscopy and Conscious Sedation, run by Soroka University Medical Center at 1 site in Israel.
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 1 inclusion and 16 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 10 Aug 2007. 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 Israel. 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?
Recovery time (time frame: 24 hours following 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 10 Aug 2007.