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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235894
• Other study ID #: Osijek UH
• Status: Completed
• Start date: September 7, 2016
• Est. completion date: October 18, 2017

Study information

• Verified date: January 2020
• Source: Osijek University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 index values.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Drug Effect
• Propofol

Intervention

Drug:
• Propofol
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Osijek University Hospital	Josip Juraj Strossmayer University of Osijek

References & Publications (18)

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. — View Citation

Bryson EO, Frost EA. Propofol abuse. Int Anesthesiol Clin. 2011 Winter;49(1):173-80. doi: 10.1097/AIA.0b013e3181f2bcb0. Review. — View Citation

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. — View Citation

Eer AS, Padmanabhan U, Leslie K. Propofol dose and incidence of dreaming during sedation. Eur J Anaesthesiol. 2009 Oct;26(10):833-6. doi: 10.1097/EJA.0b013e32832c500c. — View Citation

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. Review. — View Citation

Gyulaházi J, Varga K, Iglói E, Redl P, Kormos J, Fülesdi 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;15:11. doi: 10.1186/1471-2253-15-11. eCollection 2015. — View Citation

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. — View Citation

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. — View Citation

Köroglu 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. — View Citation

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. Review. — View Citation

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

Rosenberg RS, Van Hout S. The American Academy of Sleep Medicine Inter-scorer Reliability program: respiratory events. J Clin Sleep Med. 2014 Apr 15;10(4):447-54. doi: 10.5664/jcsm.3630. — View Citation

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. Review. — View Citation

Siclari F, Tononi G. Local aspects of sleep and wakefulness. Curr Opin Neurobiol. 2017 Jun;44:222-227. doi: 10.1016/j.conb.2017.05.008. Epub 2017 May 30. Review. — View Citation

Stait ML, Leslie K, Bailey R. Dreaming and recall during sedation for colonoscopy. Anaesth Intensive Care. 2008 Sep;36(5):685-90. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During the propofol anesthesia, max. 2 hours after start of anesthesia
Secondary	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.	During the propofol anesthesia, max. 2 hours after start of anesthesia
Secondary	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.	During the propofol anesthesia, max. 2 hours after start of anesthesia