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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879771
• Other study ID #: GIE and sleep
• Status: Recruiting
• Start date: May 7, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Shengjing Hospital
• Contact: Junchao Zhu
• Phone: +8618940257257
• Email: zhujunchao1[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Endoscopy
• General Anesthesia
• Pain
• Sleep Quality

Intervention

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

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	postoperative pain score	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
Secondary	postoperative adverse effects	assess postoperative adverse effects	24 hours after surgery