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Completed

NCT Number: NCT03453099

MAPD: Modifiable Factors Affecting Propofol Dosing

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chelsea and Westminster Hospital

London, SW109NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Pregnancy
  • Neurological disease
  • Substance abuse
  • Cardiac disease
  • Renal disease
  • Obesity

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

Treatment and study plan

Preoperative Questionnaires

Other

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 Scores

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative patient reported pain scores

    Time frame: 5 minutes

    Participants will rate their level of postoperative pain whilst at rest and whilst coughing 1hr postoperatively using a Visual Analogue Scale (1-10)

Other outcomes

  1. Postoperative Analgesia Requirements

    Time frame: 5 minutes

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

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Registry information

Official study title

Modifiable Factors Affecting the Dose of Propofol Required for Anaesthetic Induction

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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