Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation
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| ClinicalTrials.gov Identifier: NCT04397393 |
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Recruitment Status :
Terminated
(insufficient data)
First Posted : May 21, 2020
Last Update Posted : December 11, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Anesthesia IVF | Drug: Midazolam |
A pilot study will be performed on patients undergoing oocyte retrieval (OPU) for the first time, and correlated to camel milk consumption versus never consumed camel milk, as well as age, BMI (body mass index), number of follicles at the time of OPU, number of previous OPUs in other clinics, previous vaginal delivery, past medical history positive for chemo therapy, alcohol consumption, use of prescribed or illicit drugs, or chronic pain medication.
The main objective is to analyse if the consumption of camel milk, the frequency, or lack thereof correlates with the amount of the sedative drug Midazolam needed to achieve an acceptable level of sedation in order to estimate the dosage needed in both patient groups more adequately, reducing either discomfort felt at a too low an initial dosage, as well as avoiding a deeper level of sedation than needed with subsequent prolonged stay in recovery and unpleasant feelings of dizziness and drowsiness, potentially requiring antagonizing Midazolam by the use of Flumazenil, and reducing overall costs and length of stay in recovery and bed occupancy and enhancing patient experience and satisfaction.
Would this study enable the Investigators to determine further effect of camel milk on other drugs used for various other purposes, and lead to a change in dose regimen?
| Study Type : | Observational |
| Actual Enrollment : | 26 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study |
| Actual Study Start Date : | July 1, 2020 |
| Actual Primary Completion Date : | August 10, 2020 |
| Actual Study Completion Date : | August 10, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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non-camel milk consumption
non-camel milk consumption over life time
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Drug: Midazolam
Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU |
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camel milk consumption
camel milk consumption at least once during lifetime, with 2 subgroups of camel milk consumption: once, twice, three times; as well as regularly (daily, once per week, once per month, once per year).
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Drug: Midazolam
Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU |
- Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU [ Time Frame: 1 day ]Mean dosage of Midazolam for both groups (Camel milk consumption vs no camel milk consumption
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| Ages Eligible for Study: | 18 Years to 48 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Arab origin
- Female 18 -48 years of age
- BMI < 37 kg/m2
- All ovarian stimulation protocols
Exclusion Criteria:
- Previous oocyte retrieval at our center
- Post chemo therapy
- Illicit drug use
- Chronic pain medication
- Medication which is known to increase the activity of liver enzymes
- Any alcohol consumption
- Previous vaginal delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397393
| United Arab Emirates | |
| IVI Middle East Fertility Clinic | |
| Abu Dhabi, United Arab Emirates, 60202 | |
| Principal Investigator: | Nils Engelmann, MD | IVI Middle East Fertility Clinic LLC |
| Responsible Party: | Nils Engelmann, Anesthesia Consultant, ART Fertility Clinics LLC |
| ClinicalTrials.gov Identifier: | NCT04397393 |
| Other Study ID Numbers: |
1910-ABU-090-NE |
| First Posted: | May 21, 2020 Key Record Dates |
| Last Update Posted: | December 11, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Midazolam Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs |
Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |