Digestive Endoscopy, Insomnia
Conditions
Keywords
Insomnia, Digestive endoscopy, Rimazolen
Brief summary
To compare the dosage requirement of rimazolen under intravenous anesthesia between patients with insomnia and those with normal sleep pattern.
Detailed description
The investigators aim to investigate whether rimazolen dosage requirement is increased in patients with insomnia under intravenous anesthesia compared with normal sleep patterns.
Interventions
No interventions, this study is to compare the dosage requirement of ciprofol under intravenous anesthesia between insomnia group and normal sleep group.
Sponsors
Beijing Tiantan Hospital
Daxing Teaching Hospital, Capital Medical University
Hebei Medical University Third Hospital
Hengshui People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients with insomnia: 1. Age of 18 - 64 years; 2. American Society of Anesthesiologists (ASA) physical status of I - II; 3. Body mass index (BMI) of 15 - 30; 4. Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general anesthesia; 5. Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder; 6. 8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less. * Patients with normal sleep: 1. Age of 18 - 64 years; 2. ASA physical status of I - II; 3. BMI of 15 - 30; 4. Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general anesthesia; 5. No history or evidence of insomnia.
Exclusion criteria
1. Associated with any neurological disease; 2. Daily alcohol consumption; 3. Any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. History of allergy to any drug used in the study; 5. Pregnancy or breastfeeding; 6. Patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. Patients with psychological diseases who report suicidal thoughts; 9. Patients who need to work or take care of children/elderly people frequently at night.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total consumption of rimazolen | Up to 1 day | The total consumption of rimazolen for the produre. It includes the total amount of ciprofol required by the patient for the entire procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The dosage of rimazolen for induction of anesthesia | 1 day | The dosage of rimazolen for induction of anesthesia |
| The occurrence of the respiratory and cardiovascular adverse events | The day of the procedure and 24 hours after the procedure | The occurrence of the respiratory and cardiovascular adverse events such as hypoxemia, hypotension, hypertension, arrhythmia |
| The occurrence of the other adverse events | The day of the procedure and 24 hours after the procedure | The occurrence of the other adverse events such as dizziness, agitation, nausea, vomiting and psychiatric symptom |
| The incidence of intraoperative recall or awareness | The day of the procedure and 24 hours after the procedure | The patient is conscious after anesthesia |
| The recovery time | Up to 1 day | The time from when the patient stops intravenous anesthetic drug application to when they can open their eyes and nod their heads. |
| Duration of patients' PACU stay | Up to 1 day | Patients' stay time in PACU |
| The ease of operation at this level of sedation evaluated by the operation doctors | Up to 1 day | The ease of operation at this level of sedation (easy/medium/difficult) evaluated by the operation doctors |
| The satisfaction degree of anesthesia effect evaluated by the operation doctors | Up to 1 day | The satisfaction degree of anesthesia effect (satisfactory/medium/unsatisfactory) evaluated by the operation doctors |
| Patients' satisfaction | Up to 1 day | Patients' satisfaction with the procedure at this level of sedation (satisfactory/medium/unsatisfactory) |
| Patients' willingness | Up to 1 day | Patients' willingness to undergo the next procedure at the same level of sedation. Patient willingness is divided into three levels: willing, moderate, and unwilling. |
Countries
China
Outcome results
None listed