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

NCT04879771 | Unknown

• 1 other identifier: GIE and sleep
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Morning Inspections; Afternoon Inspections; Sleep Quality; Gastrointestinal Endoscopy; Pain; General Anesthesia

Outcome Measures

Primary Outcomes (2)

• postoperative sleep quality

  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

  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

Secondary Outcomes (2)

• postoperative pain score

  24 hours after surgery

• postoperative adverse effects

  24 hours after surgery

Study Arms (2)

Morning GIE

Procedure: Receive gastrointestinal endoscopy

Afternoon GIE

Procedure: Receive gastrointestinal endoscopy

Interventions

Receive gastrointestinal endoscopy PROCEDURE

patients receive gastrointestinal endoscopy in the morning or afternoon

Afternoon GIE; Morning GIE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Junchao Zhu

  Shengjing Hospital

  STUDY DIRECTOR

Central Study Contacts

Junchao Zhu

CONTACT

+8618940257257; zhujunchao1@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 10, 2021
• Study Start: May 7, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

CN (1)