Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation

NCT04397393 | Terminated DMC

• 1 other identifier: 1910-ABU-090-NE
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; IVF

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Study Arms (2)

non-camel milk consumption

non-camel milk consumption over life time

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).

Drug: Midazolam

Interventions

Midazolam DRUG

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

camel milk consumption; non-camel milk consumption

Eligibility Criteria

• Age: 18 Years - 48 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

population is defined by all females of Arab origin, booked for oocyte retrieval for the first time in our center

You may qualify if:

• Arab origin
• Female 18 -48 years of age
• BMI \< 37 kg/m2
• All ovarian stimulation protocols

You may not qualify if:

• 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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

IVI Middle East Fertility Clinic

Abu Dhabi, 60202, United Arab Emirates

Location

Related Links

• Consumption of Camel Milk
• Gast, M., Mauboisj, L. and Adda, J. Le lait et les produits laitiers en Ahaggar. Centr. Rech. Anthr. Prehist. Ethn. 1969
• 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
• 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
• Dhingra, D.R. The component fatty acid and glycerides of the milk fats of Indian goats and sheep. Biochem. J. 27: 851-859, 1933
• Dhingra, D.R. Fatty acids and glycerides of the milk fat of camels. Biochem. J. 28: 73-78, 1934
• Ohris, S.P. and Joshi, B.K. Composition of camel milk. Indian Vet. J. 38(a): 514-516, 1961; 38(b): 604-606, 1961
• Epstein, H. The origin of the domestic animals of Africa. Vol. 2. New York. Africiana Publ. Corp. Leipzig. Edition Leipzig. 1971

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nils Engelmann, MD

  IVI Middle East Fertility Clinic LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Consultant

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 21, 2020
• Study Start: July 1, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

AE (1)