AnalgesiaNCT05330754
Caffeine Intake Inrelation to Perioperative Analgesic Consumption
An observational study of Analgesia and Caffeine, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Caffeine intake in mg
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 10 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 - 65 years old, physical status American Society of Anesthesiology (ASA) I\&II, body weight from 70-80 kg,
Who may be able to join
- Patients scheduled to undergo elective laparoscopic surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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]
- Being tested
- Caffeine intake in mg
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".
| Study group | Role | What they receive |
|---|---|---|
| Control group | No caffeine intake Receives: Dietary Supplement: Caffeine intake in mg | |
| Safe level Group | Caffeine daily intake ≤200 mg/day Receives: Dietary Supplement: Caffeine intake in mg | |
| Unsafe level group: | Caffeine daily intake >200 mg/day Receives: Dietary Supplement: Caffeine intake in mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
total intraoperative fentanyl consumption in microgram
Amount of total intraoperative fentanyl consumption in microgram
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start20 Apr 2022
- Primary completion30 Aug 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raham Hasan Mostafa, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330754
- Sponsor's protocol ID
- R 67/ 2022
- Status last verified
- Nov 2022
- First submitted
- 8 Apr 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Daily Caffeine Intake On Perioperative Analgesic Consumption And Recovery Time In Patients Undergoing Laparoscopic Surgeries.
- ClinicalTrials.gov ID
- NCT05330754
- Acronym / sponsor ID
- R 67/ 2022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Dietary Supplement: Caffeine intake in mgNo caffeine intake |
| Safe level Group | – | Dietary Supplement: Caffeine intake in mgCaffeine daily intake ≤200 mg/day |
| Unsafe level group: | – | Dietary Supplement: Caffeine intake in mgCaffeine daily intake >200 mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 - 65 years old, physical status American Society of Anesthesiology (ASA) I\&II, body weight from 70-80 kg,
Key inclusion criteria (1 listed)
- Patients scheduled to undergo elective laparoscopic surgery
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine intake in mgPreanesthetic 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". | Dietary supplement | Control group, Safe level Group, Unsafe level group: |
Primary outcome
total intraoperative fentanyl consumption in microgram
Time frame: 2 hours
Amount of total intraoperative fentanyl consumption in microgram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Caffeine, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total intraoperative fentanyl consumption in microgram (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.