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CompletedNCT03453099Updated Feb 5, 2020

MAPD: Modifiable Factors Affecting Propofol Dosing

An observational study in Anesthesia, sponsored by Chelsea and Westminster NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
91
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anesthesia

Keywords

  • propofol
  • anaesthetic dose
  • sleep
  • caffeine
  • anxiety
  • induction
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patient scheduled for day case general anasethesia at Chelsea \& Westminster hospital who satisfy the listed inclusion and exclusion criteria

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria

  1. Pregnancy
  2. Neurological disease
  3. Substance abuse
  4. Cardiac disease
  5. Renal disease
  6. Obesity

Additional exclusion criteria include:

  1. Any patient requiring adjunctive analgesia including local/epidural/spinal anaesthesia.
  2. Any patient requiring an anesthetic induction regime other than propofol-fentanyl (inc. administration of benzodiazepines or other strong opioids).
  3. Any patient who does not receive a standard anaesthetic induction regime due to clinical need
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
91 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Preoperative Questionnaires · Other: Postoperative Subjective Pain Scores

Interventions

  • OtherPreoperative Questionnaires

    The 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

  • OtherPostoperative Subjective Pain Scores

    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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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)

    Time frame: 5 minutes

Other outcomes

  1. Postoperative Analgesia Requirements

    A member of the research team will passively record the amount of analgesia required at 1hr postoperatively

    Time frame: 5 minutes

06

Study locations

1 site
  • Chelsea and Westminster Hospital
    London, SW109NH, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03453099
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Apr 1, 2018
Primary completion
Dec 1, 2018
Completion
Aug 31, 2019
Last update
Feb 5, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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