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AnesthesiaNCT04235894

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

An observational study of Anesthesia and Propofol, run by Osijek University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Propofol, Drug Effect
What is being tested?
Propofol
Type of treatment
Injection or infusion
How many people
124 participants
Where
No sites listed yet
Study dates
7 Sep 2016to 18 Oct 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • . 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.

About this study

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.

Read the 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.

Being tested
Propofol
Keywords
Propofol;, Endoscopy, Gastrointestinal;, Dreams;, Facial expression;, Smiling
Medical subject headings
Facial Expression, Smiling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    Also called Diprivan

    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

Study groups in NCT04235894
Study groupRoleWhat they receive
Patients undergoing GI endoscopy at Osijek University HospitalObservational 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.
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: On the emergence of anesthesia, max. 2 hours after start of anesthesia

Secondary outcomes (3)

  1. Bispectral index values during the procedure

    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.

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

  2. Blood pressure values during the procedure

    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.

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

  3. Pulse values during the procedure

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start7 Sep 2016
  3. Primary completion18 Oct 2017
  4. Study completion18 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235894
Sponsor's protocol ID
Osijek UH
Status last verified
Jan 2020
First submitted
1 Jan 2020
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leslie K, Kave B. Complications and unplanned admissions in nonoperating room procedures. Curr Opin Anaesthesiol. 2017 Dec;30(6):658-662. doi: 10.1097/ACO.0000000000000519.

    PubMed 28915133

  • Wang D, Chen C, Chen J, Xu Y, Wang L, Zhu Z, Deng D, Chen J, Long A, Tang D, Liu J. The use of propofol as a sedative agent in gastrointestinal endoscopy: a meta-analysis. PLoS One. 2013;8(1):e53311. doi: 10.1371/journal.pone.0053311. Epub 2013 Jan 8.

    PubMed 23308191

  • Koroglu G, Tezcan AH. A Case Report of the First Propofol Addiction in Turkey. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):434-6. doi: 10.5152/TJAR.2015.54872. Epub 2015 Dec 1.

    PubMed 27366543

  • Levy RJ. Clinical effects and lethal and forensic aspects of propofol. J Forensic Sci. 2011 Jan;56 Suppl 1(0 1):S142-7. doi: 10.1111/j.1556-4029.2010.01583.x. Epub 2010 Oct 15.

    PubMed 20950316

  • Ellett ML. Review of propofol and auxiliary medications used for sedation. Gastroenterol Nurs. 2010 Jul-Aug;33(4):284-95; quiz 296-7. doi: 10.1097/SGA.0b013e3181eac371.

    PubMed 20679780

  • Bryson EO, Frost EA. Propofol abuse. Int Anesthesiol Clin. 2011 Winter;49(1):173-80. doi: 10.1097/AIA.0b013e3181f2bcb0. No abstract available.

    PubMed 21239913

  • Horiuchi A, Nakayama Y, Kajiyama M, Kato N, Kamijima T, Ichise Y, Tanaka N. Safety and effectiveness of propofol sedation during and after outpatient colonoscopy. World J Gastroenterol. 2012 Jul 14;18(26):3420-5. doi: 10.3748/wjg.v18.i26.3420.

    PubMed 22807612

  • Tezcan AH, Ornek DH, Ozlu O, Baydar M, Yavuz N, Ozaslan NG, Dilek K, Keske A. Abuse potential assessment of propofol by its subjective effects after sedation. Pak J Med Sci. 2014 Nov-Dec;30(6):1247-52. doi: 10.12669/pjms.306.5811.

    PubMed 25674117

  • Roussin A, Montastruc JL, Lapeyre-Mestre M. Pharmacological and clinical evidences on the potential for abuse and dependence of propofol: a review of the literature. Fundam Clin Pharmacol. 2007 Oct;21(5):459-66. doi: 10.1111/j.1472-8206.2007.00497.x.

    PubMed 17868199

  • Jeon YT. Propofol as a controlled substance: poison or remedy. Korean J Anesthesiol. 2015 Dec;68(6):525-6. doi: 10.4097/kjae.2015.68.6.525. Epub 2015 Nov 25. No abstract available.

    PubMed 26634074

  • Stait ML, Leslie K, Bailey R. Dreaming and recall during sedation for colonoscopy. Anaesth Intensive Care. 2008 Sep;36(5):685-90. doi: 10.1177/0310057X0803600509.

    PubMed 18853587

  • Xu G, Liu X, Sheng Q, Yu F, Wang K. Sex differences in dreaming during short propofol sedation for upper gastrointestinal endoscopy. Neuroreport. 2013 Oct 2;24(14):797-802. doi: 10.1097/WNR.0b013e3283644b66.

    PubMed 23863717

  • Gyulahazi J, Varga K, Igloi E, Redl P, Kormos J, Fulesdi B. The effect of preoperative suggestions on perioperative dreams and dream recalls after administration of different general anesthetic combinations: a randomized trial in maxillofacial surgery. BMC Anesthesiol. 2015 Jan 28;15(1):11. doi: 10.1186/1471-2253-15-11. eCollection 2015.

    PubMed 25685056

  • Bagchi D, Mandal MC, Basu SR. Arousal time from sedation during spinal anaesthesia for elective infraumbilical surgeries: Comparison between propofol and midazolam. Indian J Anaesth. 2014 Jul;58(4):403-9. doi: 10.4103/0019-5049.138972.

    PubMed 25197107

  • Cascella M, Fusco R, Caliendo D, Granata V, Carbone D, Muzio MR, Laurelli G, Greggi S, Falcone F, Forte CA, Cuomo A. Anesthetic dreaming, anesthesia awareness and patient satisfaction after deep sedation with propofol target controlled infusion: A prospective cohort study of patients undergoing day case breast surgery. Oncotarget. 2017 Apr 19;8(45):79248-79256. doi: 10.18632/oncotarget.17238. eCollection 2017 Oct 3.

    PubMed 29108303

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia and Propofol, run by Osijek University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observer rating score after the procedure (time frame: On the emergence of anesthesia, max. 2 hours after start of anesthesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235894, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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