NCT07517484

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 3, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 29, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 26, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

lightanesthesiasedation depth

Outcome Measures

Primary Outcomes (1)

  • The dose of sedative medications

    The dose of sedative medications required during the induction period in patients

    Perioperative

Secondary Outcomes (3)

  • Induction time of anesthesia

    Perioperative

  • total dose of sedative medications

    during surgery

  • emergence time

    Perioperative

Study Arms (2)

the light-shielded group

EXPERIMENTAL

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.

Device: eye mask

the non-light-shielded group

NO INTERVENTION

Interventions

eye maskDEVICE

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.

the light-shielded group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Related Publications (16)

  • Boatright JH, Rubim NM, Iuvone PM. Regulation of endogenous dopamine release in amphibian retina by gamma-aminobutyric acid and glycine. Vis Neurosci. 1994 Sep-Oct;11(5):1003-12. doi: 10.1017/s095252380000393x.

    PMID: 7947393BACKGROUND
  • 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.

    PMID: 30236240BACKGROUND
  • 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.

    PMID: 34488646BACKGROUND
  • 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.

    PMID: 32807382BACKGROUND
  • 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.

    PMID: 38253963BACKGROUND
  • 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.

    PMID: 34217920BACKGROUND
  • 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.

    PMID: 28214594BACKGROUND
  • 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.

    PMID: 33065729BACKGROUND
  • 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.

    PMID: 11025337BACKGROUND
  • 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.

    PMID: 37858331BACKGROUND
  • 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.

    PMID: 24917305BACKGROUND
  • 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.

    PMID: 24010846BACKGROUND
  • 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.

    PMID: 15504186BACKGROUND
  • Sear JW. Practical treatment recommendations for the safe use of anaesthetics. Drugs. 1992 Jan;43(1):54-68. doi: 10.2165/00003495-199243010-00006.

    PMID: 1372860BACKGROUND
  • 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.

    PMID: 23962378BACKGROUND
  • 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.

    PMID: 16751211BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Data analyst
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Anesthesiology

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 8, 2026

Study Start

October 3, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 29, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

To protect patient privacy and ensure the security of clinical data, the individual participant data (IPD) collected in this study will be used only for scientific analysis and publication related to this trial. No public disclosure, sharing, or uploading to public repositories is planned. Therefore, IPD will not be made available.

Locations