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

NCT ID: NCT04879771

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2021-12-31

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. 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?

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Morning GIE

Receive gastrointestinal endoscopy

Intervention Type: PROCEDURE

patients receive gastrointestinal endoscopy in the morning or afternoon

Afternoon GIE

Receive gastrointestinal endoscopy

Intervention Type: PROCEDURE

patients receive gastrointestinal endoscopy in the morning or afternoon

Interventions

Receive gastrointestinal endoscopy

patients receive gastrointestinal endoscopy in the morning or afternoon

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yanchao Yang

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junchao Zhu

Role: STUDY_DIRECTOR

Shengjing Hospital

Locations

Shengjing Hospital

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Junchao Zhu

Role: CONTACT

zhujunchao1@hotmail.com

+8618940257257

Facility Contacts

Junchao Zhu

Role: primary

zhujunchao1@hotmail.com

+8618940257257

Other Identifiers

GIE and sleep

Identifier Type: -

Identifier Source: org_study_id