Clinical trial NCT04235894: An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Official title: An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Propofol
Drug Effect
Keywords: Propofol;
Endoscopy, Gastrointestinal;
Dreams;
Facial expression;
Smiling
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
Collaborators: name: Josip Juraj Strossmayer University of Osijek
First posted: 2020-01-22
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Observer rating score after the procedure
timeFrame: On the emergence of anesthesia, max. 2 hours after start of anesthesia
Secondary outcomes:
measure: Bispectral index values during the procedure
timeFrame: During the propofol anesthesia, max. 2 hours after start of anesthesia
measure: Blood pressure values during the procedure
timeFrame: During the propofol anesthesia, max. 2 hours after start of anesthesia
measure: Pulse values during the procedure
timeFrame: During the propofol anesthesia, max. 2 hours after start of anesthesia
Other outcomes:
Locations:
Study officials:
affiliation: Department of emergency medicine, Brodsko-posavska county; Croatia
name: Helena Matus, MD
role: PRINCIPAL_INVESTIGATOR
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