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

NCT04235894 | Completed

• 1 other identifier: Osijek UH
• Study Type: observational
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia; Propofol; Drug Effect

Keywords

Propofol;; Endoscopy, Gastrointestinal;; Dreams;; Facial expression;; Smiling

Outcome Measures

Primary Outcomes (1)

• Observer rating score after the procedure

  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 Outcomes (3)

• Bispectral index values during the procedure

  During the propofol anesthesia, max. 2 hours after start of anesthesia

• Blood pressure values during the procedure

  During the propofol anesthesia, max. 2 hours after start of anesthesia

• Pulse values during the procedure

  During the propofol anesthesia, max. 2 hours after start of anesthesia

Study Arms (1)

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

Interventions

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

Also known as: Diprivan

Patients undergoing GI endoscopy at Osijek University Hospital

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osijek University Hospital: lead
• Josip Juraj Strossmayer University of Osijek: collaborator

Related Publications (19)

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• Matus H, Kvolik S, Rakipovic A, Borzan V. Bispectral Index Monitoring and Observer Rating Scale Correlate with Dreaming during Propofol Anesthesia for Gastrointestinal Endoscopies. Medicina (Kaunas). 2021 Dec 31;58(1):62. doi: 10.3390/medicina58010062.

  PMID: 35056370 DERIVED

MeSH Terms

Conditions

Facial Expression; Smiling

Interventions

Propofol

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Helena Matus, MD

  Department of emergency medicine, Brodsko-posavska county; Croatia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 22, 2020
• Study Start: September 7, 2016
• Primary Completion: October 18, 2017
• Study Completion: October 18, 2017
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share