NCT05330754

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

April 8, 2022

Last Update Submit

November 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • total intraoperative fentanyl consumption in microgram

    Amount of total intraoperative fentanyl consumption in microgram

    2 hours

Study Arms (3)

Control group

No caffeine intake

Dietary Supplement: Caffeine intake in mg

Safe level Group

Caffeine daily intake ≤200 mg/day

Dietary Supplement: Caffeine intake in mg

Unsafe level group:

Caffeine daily intake \>200 mg/day

Dietary Supplement: Caffeine intake in mg

Interventions

Caffeine intake in mgDIETARY_SUPPLEMENT

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".

Control groupSafe level GroupUnsafe level group:

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 - 65 years old, physical status American Society of Anesthesiology (ASA) I\&II, body weight from 70-80 kg,

You may qualify if:

  • Patients scheduled to undergo elective laparoscopic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 15, 2022

Study Start

April 20, 2022

Primary Completion

August 30, 2022

Study Completion

September 10, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request

Locations