Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation

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.

Study Overview

• Status: Terminated
• Conditions: Anesthesia; IVF
• Intervention / Treatment: Drug: Midazolam

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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 60202
    • IVI Middle East Fertility Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-camel milk consumption; non-camel milk consumption over life time	Drug: Midazolam; 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).	Drug: Midazolam; Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ART Fertility Clinics LLC
• Investigators: Principal Investigator: Nils Engelmann, MD, IVI Middle East Fertility Clinic LLC

Publications and helpful links

Helpful 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
• Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): August 10, 2020
• Study Completion (Actual): August 10, 2020

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 1910-ABU-090-NE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No