Clinical trial NCT03453099: MAPD: Modifiable Factors Affecting Propofol Dosing
Official title: Modifiable Factors Affecting the Dose of Propofol Required for Anaesthetic Induction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: propofol
anaesthetic dose
sleep
caffeine
anxiety
induction
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility 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

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

Primary outcomes:
measure: The dose of propofol required for anaesthetic induction
timeFrame: 10 minutes
Secondary outcomes:
measure: Postoperative patient reported pain scores
timeFrame: 5 minutes
Other outcomes:
measure: Postoperative Analgesia Requirements
timeFrame: 5 minutes
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
References: