Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation

Anesthesia Clinical Trial

Official title:

Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04397393
• Other study ID #: 1910-ABU-090-NE
• Status: Terminated
• Start date: July 1, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: December 2020
• Source: ART Fertility Clinics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: August 10, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• IVF

Intervention

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

Locations

Country	Name	City	State
United Arab Emirates	IVI Middle East Fertility Clinic	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia
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•   Epstein, H. The origin of the domestic animals of Africa. Vol. 2. New York. Africiana Publ. Corp. Leipzig. Edition Leipzig. 1971
•   Gast, M., Mauboisj, L. and Adda, J. Le lait et les produits laitiers en Ahaggar. Centr. Rech. Anthr. Prehist. Ethn. 1969
•   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
•   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
•   Ohris, S.P. and Joshi, B.K. Composition of camel milk. Indian Vet. J. 38(a): 514-516, 1961; 38(b): 604-606, 1961
•   Yasin, S.A. and Wahid, A. Pakistan camels. A preliminary survey. Agric. Pakist. 8: 289-297, 1957