AnesthesiaNCT04397393
Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation
An observational study of Anesthesia and IVF, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
The primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, IVF
- What is being tested?
- Midazolam
- How many people
- 26 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jul 2020to 10 Aug 2020
- Phase
- Observational
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: population is defined by all females of Arab origin, booked for oocyte retrieval for the first time in our center
Who may be able to join
- Arab origin
- Female 18 -48 years of age
- BMI < 37 kg/m2
- All ovarian stimulation protocols
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertility Clinic
Abu Dhabi, 60202
About this study
Official title: Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study
The primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk.
Read the detailed description
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?
- Conditions
- Anesthesia, IVF
- Being tested
- Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU
| Study group | Role | What they receive |
|---|---|---|
| non-camel milk consumption | non-camel milk consumption over life time Receives: Drug: Midazolam | |
| 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). Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU
Mean dosage of Midazolam for both groups (Camel milk consumption vs no camel milk consumption
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jul 2020
- Primary completion10 Aug 2020
- Study completion10 Aug 2020
Why it stopped: insufficient data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Engelmann, ART Fertility Clinics LLC
- Investigators
- Nils Engelmann, MD, Principal investigator, IVI Middle East Fertility Clinic LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397393
- Sponsor's protocol ID
- 1910-ABU-090-NE
- Status last verified
- Dec 2020
- First submitted
- 17 May 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study
- ClinicalTrials.gov ID
- NCT04397393
- Acronym / sponsor ID
- 1910-ABU-090-NE
- Conditions
- Anesthesia, IVF
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient data
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 21 May 2020 (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 primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-camel milk consumption | – | Drug: Midazolamnon-camel milk consumption over life time |
| camel milk consumption | – | Drug: Midazolamcamel 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). |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- population is defined by all females of Arab origin, booked for oocyte retrieval for the first time in our center
Key inclusion criteria (4 listed)
- Arab origin
- Female 18 -48 years of age
- BMI < 37 kg/m2
- All ovarian stimulation protocols
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| MidazolamDosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU | Drug | camel milk consumption, non-camel milk consumption |
Primary outcome
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
Results and safety
The study was stopped early (reason given: insufficient data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Consumption of Camel MilkLink provided by the sponsor.
- Gast, M., Mauboisj, L. and Adda, J. Le lait et les produits laitiers en Ahaggar. Centr. Rech. Anthr. Prehist. Ethn. 1969Link provided by the sponsor.
- Kuchabaev, K.A. Cherepanova, V.P. and Panomarev P.P. Feeding, milk productivity and chemical composition of camel milk. : 58-62, 1972.El-Bahay, 1962Link provided by the sponsor.
- Kon, S.K. Milk and milk products for human nutrition. FAO Nutrition Serv. 7, p. 6, 1959 (Revised in 1972)., Knoess, K.H. Milk production of the dromedary. In: Camels. IFS Symposium, Sudan. 201-214, 1979Link provided by the sponsor.
- Dhingra, D.R. The component fatty acid and glycerides of the milk fats of Indian goats and sheep. Biochem. J. 27: 851-859, 1933Link provided by the sponsor.
- Dhingra, D.R. Fatty acids and glycerides of the milk fat of camels. Biochem. J. 28: 73-78, 1934Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Nils Engelmann, MD principal investigator
IVI Middle East Fertility Clinic LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and IVF, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Dec 2020. 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 United Arab Emirates. 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.
Are results available for this study?
The study was stopped early (reason given: insufficient data). Results are not available in the source record.
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?
Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU (time frame: 1 day). 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 11 Dec 2020.