Caffeine Intake Inrelation to Perioperative Analgesic Consumption

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05330754

Collaborator

(none)

Enrollment

Location

5.8

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Apr 20, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 15, 2022

Arms and Interventions

Arm	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".

Arm

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

Primary Outcome Measures

total intraoperative fentanyl consumption in microgram [2 hours]
Amount of total intraoperative fentanyl consumption in microgram

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 15, 2022

Last Update Posted:

May 12, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Caffeine

Study Results

No Results Posted as of May 12, 2022