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Comparison of Receiving Painless Gastrointestinal Endoscopy in the Morning or Afternoon on Postoperative Sleep Quality

7 maj 2021 uppdaterad av: Yanchao Yang, Shengjing Hospital

Gastrointestinal endoscopy (GIE) are important examinations for screening, diagnosing, and treating a variety of gastrointestinal diseases. Specifically, endoscopy is one of the best surveillance tools for early detection of several cancers, GIE is increasingly being used because of government support for cancer screening and growing interest in preventive medicine. But some patients refuse endoscopic examinations because of fear and anxiety of discomfort during the procedure. Sedatives is increasingly used in GIE these years to reduce the anxiety and discomfort of patients and increase patient satisfaction. Sedatives also minimize the risk of patient injury during GIE and provide ideal working conditions for endoscopists to improve patients' satisfaction with surgery. Sedation can be divided into four levels: minimal sedation (anxiolysis), conscious sedation, deep sedation, and general anesthesia. A combination of benzodiazepines and opiates (midazolam and fentanyl), the medications used most commonly by gastroenterologists for procedural sedation, provides adequate analgesia and sedation during colonoscopy. Besides above, propofol is an intravenously administered hypnotic drug used for induction and maintenance of general anaesthesia and is also used in procedural sedation. Nowadays, propofol sedation is preferred by more and more endoscopists for colonoscopy procedures with its perceived benefits of rapid postprocedure drug clearance, improved patient comfort and rapid recovery/discharge when compared to conventional sedation. And propofol provided more rapid recovery than midazolam, it has the merit of post-procedure neuropsychologic function over midazolam. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. At present, there are few studies that have assessed the effect of circadian rhythm during different timings of gastrointestinal endoscopy on postoperative sleep quality, and pain under general anesthesia.

Based on these considerations, we sought to answer the questions in this study:

  1. What is the impact of morning operation and evening operation on the intraoperative anesthetic requirement under general anesthesia?
  2. What are the effects of different timings of surgery on the postoperative sleep quality and pain under general anesthesia?

Studieöversikt

Studietyp

Observationell

Inskrivning (Förväntat)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Liaoning
      • Shenyang, Liaoning, Kina, 110004
        • Rekrytering
        • Shengjing Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Patients who received gastrointestinal endoscopy under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study

Beskrivning

Inclusion Criteria:

  • age between 18 and 65 years,
  • ASA physical status of I or II.

Exclusion Criteria:

  • presence of sleep disorders
  • pain syndrome
  • cardiovascular disease
  • sleep apnea syndrome
  • psychosis
  • history of opioid usage
  • history of abnormal operation or anesthesia recovery
  • unwillingness to provide informed consent
  • patient with a language communication disorder.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Morning GIE
patients receive gastrointestinal endoscopy in the morning or afternoon
Afternoon GIE
patients receive gastrointestinal endoscopy in the morning or afternoon

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
postoperative sleep quality
Tidsram: first night after inspections
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
first night after inspections
postoperative sleep quality
Tidsram: second night after inspections
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
second night after inspections

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
postoperative pain score
Tidsram: 24 hours after surgery
assess pain level by using VAS score Postoperative pain scores were evaluated by the visual analog scale (VAS) score,15 where 0 indicates painlessness, and 10 indicates severe pain. The VAS score was measured at 1, 6, 12, and 24 hours postoperatively
24 hours after surgery
postoperative adverse effects
Tidsram: 24 hours after surgery
assess postoperative adverse effects
24 hours after surgery

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 maj 2021

Primärt slutförande (Förväntat)

31 december 2021

Avslutad studie (Förväntat)

31 december 2021

Studieregistreringsdatum

Först inskickad

7 maj 2021

Först inskickad som uppfyllde QC-kriterierna

7 maj 2021

Första postat (Faktisk)

10 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 maj 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 maj 2021

Senast verifierad

1 maj 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • GIE and sleep

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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produkt tillverkad i och exporterad från U.S.A.

Nej

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