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Recruiting NCT07517484

Light and Anesthesia

No phase Interventional Light Anesthesia Sedation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eye mask.
Who it may be relevant to
Registry conditions: Light, Anesthesia, Sedation. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects and Mechanisms of Ambient Light Intensity on the Depth of General Anesthesia

Overview

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

Interventions

  • Device eye mask
    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.

Primary outcome measures

  • The dose of sedative medications [Time frame: Perioperative]
Secondary outcome measures (3)
  • Induction time of anesthesia [Time frame: Perioperative]
  • total dose of sedative medications [Time frame: during surgery]
  • emergence time [Time frame: Perioperative]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Publications

  • 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 7947393
  • 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 30236240
  • 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 34488646
  • 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 32807382
  • 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 38253963
  • 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 34217920
  • 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 28214594
  • 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 33065729

Identifiers

NCT: NCT07517484 · 2025-h018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗