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Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation

NCT ID: NCT04397393

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-08-10

Brief Summary

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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

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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

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Anesthesia IVF

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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non-camel milk consumption

non-camel milk consumption over life time

Midazolam

Intervention Type DRUG

Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU

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).

Midazolam

Intervention Type DRUG

Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU

Interventions

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Midazolam

Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Nils Engelmann

Anesthesia Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nils Engelmann, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Middle East Fertility Clinic LLC

Locations

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IVI Middle East Fertility Clinic

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Related Links

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http://www.fao.org/3/X6528E/X6528E03.htm#chIII.

Consumption of Camel Milk

http://www.fao.org/3/X6528E/X6528E11.htm

Gast, M., Mauboisj, L. and Adda, J. Le lait et les produits laitiers en Ahaggar. Centr. Rech. Anthr. Prehist. Ethn. 1969

http://www.fao.org/3/X6528E/X6528E11.htm

Kuchabaev, K.A. Cherepanova, V.P. and Panomarev P.P. Feeding, milk productivity and chemical composition of camel milk. : 58-62, 1972.El-Bahay, 1962

http://www.fao.org/3/X6528E/X6528E11.htm

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, 1979

http://www.fao.org/3/X6528E/X6528E11.htm

Dhingra, D.R. The component fatty acid and glycerides of the milk fats of Indian goats and sheep. Biochem. J. 27: 851-859, 1933

http://www.fao.org/3/X6528E/X6528E11.htm

Dhingra, D.R. Fatty acids and glycerides of the milk fat of camels. Biochem. J. 28: 73-78, 1934

http://www.fao.org/3/X6528E/X6528E11.htm

Ohris, S.P. and Joshi, B.K. Composition of camel milk. Indian Vet. J. 38(a): 514-516, 1961; 38(b): 604-606, 1961

http://www.fao.org/3/X6528E/X6528E11.htm

Epstein, H. The origin of the domestic animals of Africa. Vol. 2. New York. Africiana Publ. Corp. Leipzig. Edition Leipzig. 1971

Other Identifiers

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1910-ABU-090-NE

Identifier Type: -

Identifier Source: org_study_id