AnesthesiaNCT03453099
MAPD: Modifiable Factors Affecting Propofol Dosing
An observational study of Anesthesia, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators aim to understand the effect of a caffeine intake, sleep habits, anxiety about surgery, alcohol intake and smoking status upon the dose of the anaesthetic drug, propofol, required for anaesthetic induction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Preoperative Questionnaires and Postoperative Subjective Pain Scores
- How many people
- 91 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 31 Aug 2019
- 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: All patient scheduled for day case general anasethesia at Chelsea \& Westminster hospital who satisfy the listed inclusion and exclusion criteria
Who may be able to join
- ASA I or II patients scheduled for elective day case general anaesthesia with Laryngeal Mask Airway (LMA) airway insertion and a standard propofol-fentanyl induction, aged between 18-65 years at Chelsea \& Westminster Hospital.
Who cannot join
- Pregnancy
- Neurological disease
- Substance abuse
- Cardiac disease
- Renal disease
- Obesity
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- Additional exclusion criteria include:
- Any patient requiring adjunctive analgesia including local/epidural/spinal anaesthesia.
- Any patient requiring an anesthetic induction regime other than propofol-fentanyl (inc. administration of benzodiazepines or other strong opioids).
- Any patient who does not receive a standard anaesthetic induction regime due to clinical need
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifiable Factors Affecting the Dose of Propofol Required for Anaesthetic Induction
The investigators aim to understand the effect of a caffeine intake, sleep habits, anxiety about surgery, alcohol intake and smoking status upon the dose of the anaesthetic drug, propofol, required for anaesthetic induction.
Read the detailed description
The investigators hypothesise that modifiable environmental factors may cause reversible changes in a patients neurobiology which affect their responsiveness to anaesthetic drugs. Such factors may include chronic caffeine intake, chronic sleep deprivation, acute anxiety about surgery, alcohol intake and smoking. Investigation of the relationship between such factors and the dose of anaesthetic required for loss of consciousness may not only allow for better prediction of dose requirements but may also allow for optimisation of patients prior to undergoing general anaesthesia with a view to decreasing anaesthetic dose requirements and the complications associated with this.
To address this questions, the investigators will be asking patients admitted for any day case surgery at Chelsea \& Westminster hospital to complete five short questionnaires and a demographic sheet addressing 1) Caffeine intake 2) Sleep habits 3) Anxiety about the operation 4) Alcohol intake 5) Smoking status.
This will then be compared to the amount of the anaesthetic drug Propofol required and the time taken to induce loss of consciousness prior to surgery. Loss of consciousness will be measured subjectively by loss of eye opening response and loss of verbal response when a patient is asked to count upwards from 1.
The investigators also wish to investigate whether these same 5 factors affect patient reported postoperative pain and analgesia requirements. As such the investigators will also ask participants to rate their level of pain whilst at rest and whilst coughing at 1 hour after the operation. We will also record how much analgesia is requested and received in the postoperative period.
- Conditions
- Anesthesia
- Being tested
- Preoperative Questionnaires, Postoperative Subjective Pain Scores
- Keywords
- propofol, anaesthetic dose, sleep, caffeine, anxiety, induction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative QuestionnairesOther
The participants will be asked to complete 5 questionnaires:
- An abbreviated version of the Caffeine Assessment Tool (CAT)
- Sleep Questionnaire (SQ)
- Surgical Fear Questionnaire (SFQ)
- WHO Alcohol AUDIT Tool
- WHO Smoking Questionnaire
They will also be asked to complete a demographics sheet
All participants will undergo standard anaesthetic induction, a research participant will observe the dose of propofol and time taken for loss of consciousness
Postoperative Subjective Pain ScoresOther
After the operation, participants will be provide with a scale from 1-10 in which to rate their pain at rest and whilst coughing. This will be undertaken at 1hr postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Any ASA I or II patients scheduled for elective day case general anaesthesia at Chelsea \& Westminster Hospital, involving a standard propofol-fentanyl induction regimen, aged between 18-65 years . See specific exclusion criteria below. Receives: Other: Preoperative Questionnaires; Other: Postoperative Subjective Pain Scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of propofol required for anaesthetic induction
Propofol will be administered at a rate of 20mg every 10 seconds by the Anaesthetist (as per national guidelines) and a member of the research team will passively record the dose of drug and the time taken for loss of consciousness as defined by a lack of eye opening and a lack of verbal response
Measured: 10 minutes
Secondary outcomes (1)
Postoperative patient reported pain scores
Participants will rate their level of postoperative pain whilst at rest and whilst coughing 1hr postoperatively using a Visual Analogue Scale (1-10)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Dec 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453099
- Sponsor's protocol ID
- 00001
- Status last verified
- Nov 2019
- First submitted
- 13 Feb 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifiable Factors Affecting the Dose of Propofol Required for Anaesthetic Induction
- ClinicalTrials.gov ID
- NCT03453099
- Acronym / sponsor ID
- 00001
- Conditions
- Anesthesia
- Keywords
- propofol, anaesthetic dose, sleep, caffeine, anxiety, induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 5 Mar 2018 (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.
The investigators aim to understand the effect of a caffeine intake, sleep habits, anxiety about surgery, alcohol intake and smoking status upon the dose of the anaesthetic drug, propofol, required for anaesthetic induction.
Detailed description
The investigators hypothesise that modifiable environmental factors may cause reversible changes in a patients neurobiology which affect their responsiveness to anaesthetic drugs. Such factors may include chronic caffeine intake, chronic sleep deprivation, acute anxiety about surgery, alcohol intake and smoking. Investigation of the relationship between such factors and the dose of anaesthetic required for loss of consciousness may not only allow for better prediction of dose requirements but may also allow for optimisation of patients prior to undergoing general anaesthesia with a view to decreasing anaesthetic dose requirements and the complications associated with this.
To address this questions, the investigators will be asking patients admitted for any day case surgery at Chelsea \& Westminster hospital to complete five short questionnaires and a demographic sheet addressing 1) Caffeine intake 2) Sleep habits 3) Anxiety about the operation 4) Alcohol intake 5) Smoking status.
This will then be compared to the amount of the anaesthetic drug Propofol required and the time taken to induce loss of consciousness prior to surgery. Loss of consciousness will be measured subjectively by loss of eye opening response and loss of verbal response when a patient is asked to count upwards from 1.
The investigators also wish to investigate whether these same 5 factors affect patient reported postoperative pain and analgesia requirements. As such the investigators will also ask participants to rate their level of pain whilst at rest and whilst coughing at 1 hour after the operation. We will also record how much analgesia is requested and received in the postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Preoperative Questionnaires, Other: Postoperative Subjective Pain ScoresAny ASA I or II patients scheduled for elective day case general anaesthesia at Chelsea \& Westminster Hospital, involving a standard propofol-fentanyl induction regimen, aged between 18-65 years . See specific exclusion criteria below. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient scheduled for day case general anasethesia at Chelsea \& Westminster hospital who satisfy the listed inclusion and exclusion criteria
Key inclusion criteria (1 listed)
- ASA I or II patients scheduled for elective day case general anaesthesia with Laryngeal Mask Airway (LMA) airway insertion and a standard propofol-fentanyl induction, aged between 18-65 years at Chelsea \& Westminster Hospital.
Key exclusion criteria (10 listed)
- Pregnancy
- Neurological disease
- Substance abuse
- Cardiac disease
- Renal 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 |
|---|---|---|
| Preoperative QuestionnairesThe participants will be asked to complete 5 questionnaires: 1. An abbreviated version of the Caffeine Assessment Tool (CAT) 2. Sleep Questionnaire (SQ) 3. Surgical Fear Questionnaire (SFQ) 4. WHO Alcohol AUDIT Tool 5. WHO Smoking Questionnaire They will also be asked to complete a demographics sheet All participants will undergo standard anaesthetic induction, a research participant will observe the dose of propofol and time taken for loss of consciousness | Other | Study Cohort |
| Postoperative Subjective Pain ScoresAfter the operation, participants will be provide with a scale from 1-10 in which to rate their pain at rest and whilst coughing. This will be undertaken at 1hr postoperatively. | Other | Study Cohort |
Primary outcome
The dose of propofol required for anaesthetic induction
Time frame: 10 minutes
Propofol will be administered at a rate of 20mg every 10 seconds by the Anaesthetist (as per national guidelines) and a member of the research team will passively record the dose of drug and the time taken for loss of consciousness as defined by a lack of eye opening and a lack of verbal response
1 secondary outcome
Postoperative patient reported pain scores
Time frame: 5 minutes
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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 Anesthesia, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 10 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 5 Feb 2020. 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 United Kingdom. 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?
The dose of propofol required for anaesthetic induction (time frame: 10 minutes). 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 5 Feb 2020.