Hemodynamics, Hysteroscopy, Sedation
Conditions
Brief summary
To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients
Interventions
DRUGEtomidate
DRUGPropofol
DRUGRemifentanil
During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2\ 0.4 μg/kg/min.
DRUGAnesthesia induction
For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.
Sponsors
Shaanxi Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 60 and 80 years 2. Selective hysteroscopic operation 3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ 4. Signed informed consent form 5. Expected operation duration is within 60 minutes
Exclusion criteria
1. Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis 2. Long use of hormone or history of adrenal suppression 3. Allergy to trial drug or other contraindication 4. History or expected difficult airway 5. Identified, suspected abuse or long use of narcotic analgesia 6. Neuromuscular diseases 7. Mentally unstable or has a mental illness 8. Dysfunction of communication 9. Trend of malignant hyperthermia 10. Pregnant or breast-feeding women 11. Attended other trial past 30 days;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotrend index | Immediately after the entrance to the operating room until until 60 minutes after the operation | Narcotrend index will be recorded immediately after the entance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation. |
| Pulse oxygen saturation | Immediately after the entrance to the operating room until until 60 minutes after the operation | Pulse oxygen saturation will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation. |
| Heart rate | Immediately after the entrance to the operating room until until 60 minutes after the operation | heart rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation. |
| Mean arterial pressure | Immediately after the entrance to the operating room until until 60 minutes after the operation | Mean arterial pressure will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation. |
| Respiratory rate | Immediately after the entrance to the operating room until until 60 minutes after the operation | Respiratory rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | from the date of admission to the day of discharge, expected to 3 days | — |
| Score of Minimum Mental State Examination | 1 day before the operation to 45 minutes after the operation | Score of Minimum Mental State Examination will be examined in preoperative visit, 10 minutes, 45 minutes after the operation |
| Verbal Fluency test | 1 day before the operation to 60 minutes after the operation | Verbal Fluency test will be examined in preoperative visit and 60 minutes after the operation |
| Cerebral injury parameters | Immediately after the entrance to the operating room until until 60 minutes after the operation | 2 ml blood will be collected immediately after the entrance to the operating room and 60 min after the operation, then SB-100 protein and neuron-specific enolase will be tested by enzyme-linked immunosorbent assay. |
Contacts
Primary ContactWenying Song
Outcome results
None listed