Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation
- Registration Number
- NCT04397393
- Lead Sponsor
- ART Fertility Clinics LLC
- Brief 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.
- 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?
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 26
- Arab origin
- Female 18 -48 years of age
- BMI < 37 kg/m2
- All ovarian stimulation protocols
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description non-camel milk consumption Midazolam non-camel milk consumption over life time camel milk consumption Midazolam 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).
- Primary Outcome Measures
Name Time Method Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU 1 day Mean dosage of Midazolam for both groups (Camel milk consumption vs no camel milk consumption
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IVI Middle East Fertility Clinic
🇦🇪Abu Dhabi, United Arab Emirates