- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05330754
Caffeine Intake Inrelation to Perioperative Analgesic Consumption
November 15, 2022 updated by: Raham Hasan Mostafa, MD, Ain Shams University
Effect Of Daily Caffeine Intake On Perioperative Analgesic Consumption And Recovery Time In Patients Undergoing Laparoscopic Surgeries.
Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood.
We designed this prospective observational study to determine if caffeine consumption would influence intraoperative analgesic consumption
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Caffeine is a well-known natural compound present in various plant products.
Caffeine is an integral component of several daily drinks, including tea, coffee, soft drinks, and energy drinks [1].
(e consumption habits of these caffeinated drinks have facilitated the wide distribution of and dependence on caffeine.
For instance, 89% of the US adult population has an average caffeine intake of 200 mg/day [2].
Among the multiple effects and side effects, caffeine also has an analgesic action and is used to reduce pain in several pharmaceutical forms as an adjuvant [1].
Several studies have reported a role for caffeine in controlling pain and suggested that caffeine may block the central processing of pain signals in the brain and enhance the body's natural pain resistance pathways [3].
In addition, Overstreet et al. found that habitual caffeine consumption diminishes pain sensitivity in a laboratory setting [4]
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Ain Shams university hospitals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
18 - 65 years old, physical status American Society of Anesthesiology (ASA) I&II, body weight from 70-80 kg,
Description
Inclusion Criteria:
- Patients scheduled to undergo elective laparoscopic surgery
Exclusion Criteria:
- Patients converted to an open surgery, postoperative complications that increased postoperative pain, and those with psychological or nervous system diseases were also excluded. Liver disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
No caffeine intake
|
Preanesthetic check-up was done.
Average daily caffeine consumption in mg was calculated according to "caffeine content in consumed drinks" as estimated by "Food Data Central".
|
Safe level Group
Caffeine daily intake ≤200 mg/day
|
Preanesthetic check-up was done.
Average daily caffeine consumption in mg was calculated according to "caffeine content in consumed drinks" as estimated by "Food Data Central".
|
Unsafe level group:
Caffeine daily intake >200 mg/day
|
Preanesthetic check-up was done.
Average daily caffeine consumption in mg was calculated according to "caffeine content in consumed drinks" as estimated by "Food Data Central".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total intraoperative fentanyl consumption in microgram
Time Frame: 2 hours
|
Amount of total intraoperative fentanyl consumption in microgram
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2022
Primary Completion (Actual)
August 30, 2022
Study Completion (Actual)
September 10, 2022
Study Registration Dates
First Submitted
April 8, 2022
First Submitted That Met QC Criteria
April 8, 2022
First Posted (Actual)
April 15, 2022
Study Record Updates
Last Update Posted (Actual)
November 16, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R 67/ 2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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