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Caffeine Intake Inrelation to Perioperative Analgesic Consumption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05330754
Recruitment Status : Completed
First Posted : April 15, 2022
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
Raham Hasan Mostafa, MD, Ain Shams University

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment
Analgesia Caffeine Dietary Supplement: Caffeine intake in mg

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 Design
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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effect Of Daily Caffeine Intake On Perioperative Analgesic Consumption And Recovery Time In Patients Undergoing Laparoscopic Surgeries.
Actual Study Start Date : April 20, 2022
Actual Primary Completion Date : August 30, 2022
Actual Study Completion Date : September 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Control group
No caffeine intake
 Dietary Supplement: Caffeine intake in mg
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
 Dietary Supplement: Caffeine intake in mg
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
 Dietary Supplement: Caffeine intake in mg
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".


Outcome Measures
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Primary Outcome Measures :
  1. total intraoperative fentanyl consumption in microgram [ Time Frame: 2 hours ]
    Amount of total intraoperative fentanyl consumption in microgram


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
Criteria

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
Contacts and Locations
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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): NCT05330754


Locations
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Egypt
Ain Shams University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
More Information
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Responsible Party: Raham Hasan Mostafa, MD, Assistant Professor of Anesthesia, Ain Shams University
ClinicalTrials.gov Identifier: NCT05330754    
Other Study ID Numbers: R 67/ 2022
First Posted: April 15, 2022    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request

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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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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents