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Completed

NCT Number: NCT04235894

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Propofol

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Collaborators

  • Josip Juraj Strossmayer University of Osijek

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 22, 2020
Registry last updated
Jan 22, 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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