MAPD: Modifiable Factors Affecting Propofol Dosing

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Other: Preoperative Questionnaires; Other: Postoperative Subjective Pain Scores

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 Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW109NH
    • Chelsea and Westminster Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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; Other: Postoperative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	5 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Analgesia Requirements	A member of the research team will passively record the amount of analgesia required at 1hr postoperatively	5 minutes

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: sleep; anxiety; caffeine; propofol; induction; anaesthetic dose
• Other Study ID Numbers: 00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No