MAPD: Modifiable Factors Affecting Propofol Dosing

NCT03453099 | Completed

• 1 other identifier: 00001
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

propofol; anaesthetic dose; sleep; caffeine; anxiety; induction

Outcome Measures

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

  10 minutes

Secondary Outcomes (1)

• Postoperative patient reported pain scores

  5 minutes

Other Outcomes (1)

• Postoperative Analgesia Requirements

  5 minutes

Study Arms (1)

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

Preoperative Questionnaires OTHER

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

Study Cohort

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.

Study Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, SW109NH, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 5, 2018
• Study Start: April 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: August 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)