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

Sponsor
Shengjing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04879771
Collaborator
(none)
100
1
7.8
12.8

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Procedure: Receive gastrointestinal endoscopy

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Receiving Painless Gastrointestinal Endoscopy in the Morning or Afternoon on Postoperative Sleep Quality
Actual Study Start Date :
May 7, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Morning GIE

Procedure: Receive gastrointestinal endoscopy
patients receive gastrointestinal endoscopy in the morning or afternoon

Afternoon GIE

Procedure: Receive gastrointestinal endoscopy
patients receive gastrointestinal endoscopy in the morning or afternoon

Outcome Measures

Primary Outcome Measures

  1. postoperative sleep quality [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

  2. postoperative sleep quality [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

Secondary Outcome Measures

  1. postoperative pain score [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

  2. postoperative adverse effects [24 hours after surgery]

    assess postoperative adverse effects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shengjing Hospital Shenyang Liaoning China 110004

Sponsors and Collaborators

  • Shengjing Hospital

Investigators

  • Study Director: Junchao Zhu, Shengjing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanchao Yang, principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT04879771
Other Study ID Numbers:
  • GIE and sleep
First Posted:
May 10, 2021
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 10, 2021