An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia

January 16, 2020 updated by: Osijek University Hospital
This study investigates correlation between dreaming in propofol anesthesia and an Observer-rating-scale of facial expression after gastrointestinal endoscopy in adults. It also compares dreamers and non-dreamers in age, BMI, propofol dose, duration of procedure, mean arterial pressure, pulse values and Bispectral index values.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After Ethical committee approval and written informed consent was obtained, a total of 124 patients undergoing gastrointestinal endoscopy were recruited in the prospective observational study. Anesthesia was maintained using incremental propofol doses until the patient was calm and unresponsive to painful stimuli. Bispectral Index (BIS), blood pressure (BP) and pulse were monitored in typical intervals: before induction, during induction, at the beginning of the procedure, at 2nd, 5th and 10th minute of the procedure, and on emergence. On the emergence of anesthesia, the patient's facial expression was rated numerically (-3 pain, +3 smile). Thereafter patients were asked to rate their dream.

Study Type

Observational

Enrollment (Actual)

124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive male and female adult patients undergoing gastrointestinal endoscopy at Osijek University Hsspital who wrote informad consent and were able to understand study protocol.

Patients younger than 18 years, those allergic to propofol and unable to understand study protocol were not included in the study. patients with procedures lasting less than 5 minutes and more than 60 minutes were excluded from the study.

Description

Inclusion Criteria:

  • Consecutive patients undergoing gastrointestinal endoscopy at Osijek University HOspital form September 2016 to October 2017.

Exclusion Criteria:

  • . Patients who were younger than 18 years, unscheduled patients who were not hemodynamically stable, those who were not able to understand study protocol, and who did not sign written informed consent were not included in the study. Patients whose procedure was longer than 60 minutes and patients with incomplete records were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing GI endoscopy at Osijek University Hospital
Observational study. A total of 130 consecutive patients undergoing gastrointestinal endoscopy were included. The anesthesia was provided with propofol, starting with 0,5 mg/kg, and titrated until a patient was unresponsive to painful stimuli and maintaining spontaneous breathing. The blood pressure, pulse and Bispectral index values were measured in 6 defined points. On the emergence from anesthesia, the patient's facial expression was rated numerically by the investigator.
Drug: Propofol
Intravenous anesthesia with propofol started with 0.5 mg kg-1, and was titrated until a patient was unresponsive to painful stimuli & maintaining spontaneous breathing during gastrointestinal endoscopy
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observer rating score after the procedure
Time Frame: On the emergence of anesthesia, max. 2 hours after start of anesthesia
On the emergence of anesthesia, Observer's: rating of facial expression was written (-3: loud expression of pain; -2: painful grimace; -1: dissatisfaction; 0: neutral; 1: satisfaction; 2: smile and 3: laughter)
On the emergence of anesthesia, max. 2 hours after start of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bispectral index values during the procedure
Time Frame: During the propofol anesthesia, max. 2 hours after start of anesthesia
Bispectral index (BIS) was measured in six points during the procedure; right before the anesthesia, one minute after the first propofol dose, immediately after the start of intervention, 2 minutes after the start of endoscopy, 5 minutes after the start of endoscopy, and finally on the emergence from anesthesia.
During the propofol anesthesia, max. 2 hours after start of anesthesia
Blood pressure values during the procedure
Time Frame: During the propofol anesthesia, max. 2 hours after start of anesthesia
Blood pressure value was measured in six points during the procedure; right before the anesthesia, one minute after the first propofol dose, immediately after the start of intervention, 2 minutes after the start of endoscopy, 5 minutes after the start of endoscopy, and finally on the emergence from anesthesia.
During the propofol anesthesia, max. 2 hours after start of anesthesia
Pulse values during the procedure
Time Frame: During the propofol anesthesia, max. 2 hours after start of anesthesia
Pulse value was measured in six points during the procedure; right before the anesthesia, one minute after the first propofol dose, immediately after the start of intervention, 2 minutes after the start of endoscopy, 5 minutes after the start of endoscopy, and finally on the emergence from anesthesia.
During the propofol anesthesia, max. 2 hours after start of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osijek University Hospital

Collaborators

Josip Juraj Strossmayer University of Osijek

Investigators

  • Principal Investigator: Helena Matus, MD, Department of emergency medicine, Brodsko-posavska county; Croatia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 7, 2016

Primary Completion (ACTUAL)

October 18, 2017

Study Completion (ACTUAL)

October 18, 2017

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (ACTUAL)

January 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Osijek UH

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Effect

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe