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

Completed

• Conditions: Drug Effect; Anesthesia; Propofol
• Interventions: Drug: Propofol

• Registration Number: NCT04235894
• Lead Sponsor: Osijek University Hospital

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.

Study Timeline

• Study Start: 2016-09-07
• Primary Completion: 2017-10-18
• Study Completion: 2017-10-18
• Status Verified: 2020-01
• Study First Submitted: 2020-01-01
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing GI endoscopy at Osijek University Hospital	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Observer rating score after the procedure	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 Outcome Measures

Name	Time	Method
Bispectral index values during the procedure	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.
Blood pressure values during the procedure	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.
Pulse values during the procedure	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.