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Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation

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ClinicalTrials.gov Identifier: NCT04397393
Recruitment Status : Terminated (insufficient data)
First Posted : May 21, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Nils Engelmann, 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.

Condition or disease Intervention/treatment
Anesthesia IVF 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?

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : August 10, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU [ Time Frame: 1 day ]
    Mean dosage of Midazolam for both groups (Camel milk consumption vs no camel milk consumption



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397393


Locations
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United Arab Emirates
IVI Middle East Fertility Clinic
Abu Dhabi, United Arab Emirates, 60202
Sponsors and Collaborators
ART Fertility Clinics LLC
Investigators
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Principal Investigator: Nils Engelmann, MD IVI Middle East Fertility Clinic LLC
Additional Information:
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Responsible Party: Nils Engelmann, Anesthesia Consultant, ART Fertility Clinics LLC
ClinicalTrials.gov Identifier: NCT04397393    
Other Study ID Numbers: 1910-ABU-090-NE
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action