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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

Tracking Information
First Submitted Date April 8, 2022
First Posted Date April 15, 2022
Last Update Posted Date November 16, 2022
Actual Study Start Date April 20, 2022
Actual Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2022)		 total intraoperative fentanyl consumption in microgram [ Time Frame: 2 hours ]
Amount of total intraoperative fentanyl consumption in microgram
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Caffeine Intake Inrelation to Perioperative Analgesic Consumption
Official Title Effect Of Daily Caffeine Intake On Perioperative Analgesic Consumption And Recovery Time In Patients Undergoing Laparoscopic Surgeries.
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
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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,
Condition
  • Analgesia
  • Caffeine
Intervention 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".
Study Groups/Cohorts
  • Control group
    No caffeine intake
    Intervention: Dietary Supplement: Caffeine intake in mg
  • Safe level Group
    Caffeine daily intake ≤200 mg/day
    Intervention: Dietary Supplement: Caffeine intake in mg
  • Unsafe level group:
    Caffeine daily intake >200 mg/day
    Intervention: Dietary Supplement: Caffeine intake in mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 8, 2022)		 90
Original Estimated Enrollment Same as current
Actual Study Completion Date September 10, 2022
Actual Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT05330754
Other Study ID Numbers R 67/ 2022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Current Responsible Party Raham Hasan Mostafa, MD, Ain Shams University
Original Responsible Party Raham Hasan Mostafa, MD, Ain Shams University, MD
Current Study Sponsor Ain Shams University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Ain Shams University
Verification Date November 2022