The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
NCT ID: NCT00376831
Last Updated: 2007-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2007-01-31
2007-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0
fentanyl
Midazolam, Fentanyl
fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
1
ketamine
KETAMINE, MIDAZOLAM
Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Midazolam, Fentanyl
fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
KETAMINE, MIDAZOLAM
Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Hypersensitivity to benzyl alcohol
3. Hypersensitivity to ketamine
4. Hypersensitivity to opiates
5. Pregnancy
6. Uncontrolled hypertension
7. Myocardial infarct in the last 6 months
8. CVA
9. Chronic pulmonary disease
10. Renal failure
11. Chronic liver disease (CHILD B or C)
12. Elevated ICP, cerebral hemorrhage or cranial SOL.
13. Hypovolemic shock
14. Glaucoma
15. Mental illness
16. Drug or alcohol addiction
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Soroka University Medical Center
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
pavel krugliak, md. professor
Role: PRINCIPAL_INVESTIGATOR
Head of the endoscopic unit at Soroka Medical Center Beer Sheva Israel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soroka Medical Center
Beersheba, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SOR440806CTIL
Identifier Type: -
Identifier Source: org_study_id