- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517484
Light and Anesthesia
Effects and Mechanisms of Ambient Light Intensity on the Depth of General Anesthesia
The objective of this clinical trial is to investigate the effect of light exposure on sedation depth during general anesthesia.The primary research questions this study aims to address include:
Does light condition affect the dosage of anesthetic medications during anesthesia? By what mechanism does light exposure exert an influence on anesthesia? Participants will be randomly allocated to either the light-shielded group or the non-light-shielded group.Patients in the light-shielded group will wear an eye shield during anesthesia.
The following data will be recorded for all patients:
Induction drug dosage Induction time Intraoperative anesthetic dosage Emergence time
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yi Feng, Ph.D
- Phone Number: 010-88325590
- Email: doctor_yifeng@sina.com
Study Contact Backup
- Name: Xiaoyan Li, Ph.D
- Phone Number: 18810599681
- Email: 2411110461@bjmu.edu.cn
Study Locations
-
-
-
Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
-
Contact:
- Xiaoyan Li
- Phone Number: 18810599681
- Email: 2411110461@bjmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- a. Age between 18 and 65 years, regardless of gender;
- b. ASA physical status I-II;
- c. 18.5 ≤ BMI ≤ 28;
- d. Signed written informed consent.
Exclusion Criteria:
- a. Blindness or history of photosensitivity disorders;
- b. Patients requiring medication for sleep, or with a history of sleep disorders;
- c. Presence of neurological diseases;
- d. Pregnancy;
- e. Severe hepatic or renal dysfunction;
- f. History of anesthetic drug abuse or alcohol abuse;
- g. History of adverse anesthesia events (difficult airway, allergy to anesthetic agents).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: the light-shielded group
Patients in the light-shielded group will wear an opaque eye mask 30 minutes prior to induction of general anesthesia and continue to do so until the cessation of sedative medications for anesthesia.
|
Patients in the light-shielded group will wear an opaque eye mask 30 minutes prior to induction of general anesthesia and continue to do so until the cessation of sedative medications for anesthesia.
|
|
No Intervention: the non-light-shielded group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The dose of sedative medications
Time Frame: Perioperative
|
The dose of sedative medications required during the induction period in patients
|
Perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Induction time of anesthesia
Time Frame: Perioperative
|
Induction time of anesthesia
|
Perioperative
|
|
total dose of sedative medications
Time Frame: during surgery
|
total dose of sedative medications required to maintain a certain range of anesthetic depth during surgery
|
during surgery
|
|
emergence time
Time Frame: Perioperative
|
emergence time after drug discontinuation
|
Perioperative
|
Collaborators and Investigators
Publications and helpful links
General Publications
- LeGates TA, Fernandez DC, Hattar S. Light as a central modulator of circadian rhythms, sleep and affect. Nat Rev Neurosci. 2014 Jul;15(7):443-54. doi: 10.1038/nrn3743. Epub 2014 Jun 11.
- Ishizawa M, Uchiumi T, Takahata M, Yamaki M, Sato T. Effects of pre-bedtime blue-light exposure on ratio of deep sleep in healthy young men. Sleep Med. 2021 Aug;84:303-307. doi: 10.1016/j.sleep.2021.05.046. Epub 2021 Jun 8.
- Touitou Y, Reinberg A, Touitou D. Association between light at night, melatonin secretion, sleep deprivation, and the internal clock: Health impacts and mechanisms of circadian disruption. Life Sci. 2017 Mar 15;173:94-106. doi: 10.1016/j.lfs.2017.02.008. Epub 2017 Feb 16.
- Boatright, J.H., N.M. Rubim, and P.M. Iuvone, REGULATION OF ENDOGENOUS DOPAMINE RELEASE IN AMPHIBIAN RETINA BY GAMMA-AMINOBUTYRIC-ACID AND GLYCINE. Visual Neuroscience, 1994. 11(5): p. 1003-1012.
- Szolnoki J, Polaner DM, Eckle T. Diurnal variations in recovery times after general anaesthesia in children. Br J Anaesth. 2018 Oct;121(4):776-786. doi: 10.1016/j.bja.2018.06.027. Epub 2018 Aug 10.
- Shen JH, Ye M, Chen Q, Chen Y, Zhao HL, Khan A, Yi B, Ning JL, Lu KZ, Gu JT. Effects of circadian rhythm on Narcotrend index and target-controlled infusion concentration of propofol anesthesia. BMC Anesthesiol. 2021 Sep 6;21(1):215. doi: 10.1186/s12871-021-01445-z.
- Wang D, Huang Y, Wang X, Chen X, Li J, Zhang S, Wu J, Liu D, Ma D, Mei W. Circadian differences in emergence from volatile anaesthesia in mice: involvement of the locus coeruleus noradrenergic system. Br J Anaesth. 2020 Oct;125(4):548-559. doi: 10.1016/j.bja.2020.07.012. Epub 2020 Aug 15.
- Shao Y, Li Y, Wang N, Xue Y, Wang T, Qiu F, Lu Y, Lan D, Wu H. Effect of daily light exposure on sleep in polar regions: A meta-analysis. J Sleep Res. 2024 Oct;33(5):e14144. doi: 10.1111/jsr.14144. Epub 2024 Jan 22.
- Barger LK, Sullivan JP, Lockley SW, Czeisler CA. Exposure to Short Wavelength-Enriched White Light and Exercise Improves Alertness and Performance in Operational NASA Flight Controllers Working Overnight Shifts. J Occup Environ Med. 2021 Feb 1;63(2):111-118. doi: 10.1097/JOM.0000000000002054.
- Daurat A, Foret J, Benoit O, Mauco G. Bright light during nighttime: effects on the circadian regulation of alertness and performance. Biol Signals Recept. 2000 Nov-Dec;9(6):309-18. doi: 10.1159/000014654.
- Dollish HK, Tsyglakova M, McClung CA. Circadian rhythms and mood disorders: Time to see the light. Neuron. 2024 Jan 3;112(1):25-40. doi: 10.1016/j.neuron.2023.09.023. Epub 2023 Oct 18.
- Ramsey DJ, Ramsey KM, Vavvas DG. Genetic advances in ophthalmology: the role of melanopsin-expressing, intrinsically photosensitive retinal ganglion cells in the circadian organization of the visual system. Semin Ophthalmol. 2013 Sep-Nov;28(5-6):406-21. doi: 10.3109/08820538.2013.825294. Epub 2013 Sep 6.
- Jensen EW, Litvan H, Struys M, Martinez Vazquez P. Pitfalls and challenges when assessing the depth of hypnosis during general anaesthesia by clinical signs and electronic indices. Acta Anaesthesiol Scand. 2004 Nov;48(10):1260-7. doi: 10.1111/j.1399-6576.2004.00521.x.
- Sear JW. Practical treatment recommendations for the safe use of anaesthetics. Drugs. 1992 Jan;43(1):54-68. doi: 10.2165/00003495-199243010-00006.
- Shepherd J, Jones J, Frampton G, Bryant J, Baxter L, Cooper K. Clinical effectiveness and cost-effectiveness of depth of anaesthesia monitoring (E-Entropy, Bispectral Index and Narcotrend): a systematic review and economic evaluation. Health Technol Assess. 2013 Aug;17(34):1-264. doi: 10.3310/hta17340.
- Bruhn J, Myles PS, Sneyd R, Struys MM. Depth of anaesthesia monitoring: what's available, what's validated and what's next? Br J Anaesth. 2006 Jul;97(1):85-94. doi: 10.1093/bja/ael120. Epub 2006 Jun 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025-h018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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