临床试验公共管理平台 Clinical Trial Management Public Platform

Screening
Baseline
Intraoperative indicators
Intraoperative secondary data
Follow-up

1.Screening

Inclusion Criteria
Exclusion Criteria
Detachment Criteria

1.1.Inclusion Criteria

Patients planning to undergo elective intraspinal anesthesia for prostate resection surgery	YES
Age 60 and above (including 60 years old)	YES
Body mass index (BMI) 18.5-30kg/m^2	YES
ASA grade I-III	YES
	YES

1.2.Exclusion Criteria

Individuals with hearing and visual impairments	NO
BMI ≥ 30	NO
Individuals with contraindications for spinal anesthesia	NO
Severe hypertension (controlled with medication, still in stage III or above hypertension), heart failure (NYHA > II)	NO
Severe bradycardia (requiring pacemaker, <60bpm)	NO
Individuals with neurological or muscular system diseases, mental illness	NO
History of sedative, antidepressant medication use, alcoholism, and drug abuse	NO
History of severe cerebrovascular disease or complication after craniocerebral trauma (e.g., emotional disorders, language disorders)	NO
Individuals with dexmedetomidine use contraindications	NO
Individuals who are unwilling or unable to communicate	NO

1.3.Detachment Criteria

loss to follow-up	NO
Subject withdraws informed consent form	NO
Change the anesthesia method to general anesthesia for patients	NO
Intraoperative use of other sedative drugs	NO
Patients transferred to ICU after surgery	NO

2.Baseline

Age
Weight
Height
BMI
Degree of education
ASA
Underlying disease

2.1.Age

Age	79 years old

2.2.Weight

Weight	65 kg

Weight

65 kg

2.3.Height

Height	1.75 m

Height

1.75 m

2.4.BMI

BMI	21.22 kg/m2

2.5.Degree of education

Degree of education	Middle school

Degree of education

Middle school

2.6.ASA

ASA	Ⅱ

ASA

Ⅱ

2.7.Underlying disease

Underlying disease	Hypertention / Diabetes

Underlying disease

Hypertention

Diabetes

3.Intraoperative indicators

Systolic pressure
Diastolic pressure
Mean arterial pressure
Heart rate
Respiratory rate
Oxygen saturation
BIS

3.1.Systolic pressure

Systolic pressure T1	187 mmHg
Systolic pressure T2	172 mmHg
Systolic pressure T3	180 mmHg
Systolic pressure T4	179 mmHg
Systolic pressure T5	167 mmHg
Systolic pressure T6	166 mmHg
Systolic pressure T7	157 mmHg
Systolic pressure T8	159 mmHg
Systolic pressure T9	154 mmHg
Systolic pressure T10	159 mmHg
Systolic pressure T11	120 mmHg
Systolic pressure T12	120 mmHg
Systolic pressure T13	122 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	88 mmHg
Diastolic pressure T2	80 mmHg
Diastolic pressure T3	85 mmHg
Diastolic pressure T4	93 mmHg
Diastolic pressure T5	89 mmHg
Diastolic pressure T6	83 mmHg
Diastolic pressure T7	81 mmHg
Diastolic pressure T8	80 mmHg
Diastolic pressure T9	75 mmHg
Diastolic pressure T10	82 mmHg
Diastolic pressure T11	59 mmHg
Diastolic pressure T12	58 mmHg
Diastolic pressure T13	59 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	121 mmHg
Mean arterial pressure T2	110 mmHg
Mean arterial pressure T3	116 mmHg
Mean arterial pressure T4	119 mmHg
Mean arterial pressure T5	118 mmHg
Mean arterial pressure T6	118 mmHg
Mean arterial pressure T7	111 mmHg
Mean arterial pressure T8	106 mmHg
Mean arterial pressure T9	101 mmHg
Mean arterial pressure T10	98 mmHg
Mean arterial pressure T11	77 mmHg
Mean arterial pressure T12	76 mmHg
Mean arterial pressure T13	76 mmHg

3.4.Heart rate

Heart rate T1	68 times/min
Heart rate T2	75 times/min
Heart rate T3	72 times/min
Heart rate T4	66 times/min
Heart rate T5	62 times/min
Heart rate T6	57 times/min
Heart rate T7	53 times/min
Heart rate T8	51 times/min
Heart rate T9	50 mmHg
Heart rate T10	50 times/min
Heart rate T11	56 times/min
Heart rate T12	56 times/min
Heart rate T13	61 times/min

3.5.Respiratory rate

Respiratory rate T1	13 times/min
Respiratory rate T2	13 times/min
Respiratory rate T3	17 times/min
Respiratory rate T4	17 times/min
Respiratory rate T5	13 times/min
Respiratory rate T6	10 times/min
Respiratory rate T7	12 times/min
Respiratory rate T8	11 times/min
Respiratory rate T9	10 times/min
Respiratory rate T10	10 times/min
Respiratory rate T11	15 times/min
Respiratory rate T12	15 times/min
Respiratory rate T13	17 times/min

3.6.Oxygen saturation

Oxygen saturation T1	98 %
Oxygen saturation T2	95 %
Oxygen saturation T3	98 %
Oxygen saturation T4	99 %
Oxygen saturation T5	100 %
Oxygen saturation T6	100 %
Oxygen saturation T7	100 %
Oxygen saturation T8	100 %
Oxygen saturation T9	100 %
Oxygen saturation T10	100 %
Oxygen saturation T11	100 %
Oxygen saturation T12	100 %
Oxygen saturation T13	100 %

3.7.BIS

BIS T1	95
BIS T2	93
BIS T3	95
BIS T4	98
BIS T5	96
BIS T6	93
BIS T7	95
BIS T8	78
BIS T9	80
BIS T10	72
BIS T11	89
BIS T12	95
BIS T13	95

4.Intraoperative secondary data

Puncture space
Dosage of ropivacaine
Sensory blockade plane
Improved Bromage score
Operation duration
Time-on
End time
Departure time
Total dosage of dexmedetomidine
Satisfaction
Special circumstances during surgery

4.1.Puncture space

Puncture space	L2-3

Puncture space

L2-3

4.2.Dosage of ropivacaine

Dosage of ropivacaine	20 mg

Dosage of ropivacaine

20 mg

4.3.Sensory blockade plane

Sensory blockade plane	T10

Sensory blockade plane

T10

4.4.Improved Bromage score

Improved Bromage score	3

Improved Bromage score

4.5.

A-VAS	0

A-VAS

4.6.Operation duration

Operation duration	213 min

Operation duration

213 min

4.7.Time-on

Time-on	14:25

Time-on

14:25

4.8.End time

End time	17:53

End time

17:53

4.9.Departure time

Departure time	17:59

Departure time

17:59

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	0 mg

Total dosage of dexmedetomidine

0 mg

4.11.Satisfaction

4.4.11.4.11.1、Operator satisfaction

Operator satisfaction	5

Operator satisfaction

4.4.11.4.11.2、Patient satisfaction

Patient satisfaction	5

Patient satisfaction

4.12.Special circumstances during surgery

4.4.12.4.12.1、Physical movement

Physical movement	NO

Physical movement

4.4.12.4.12.2、Hypoxemia

Hypoxemia	NO

Hypoxemia

4.4.12.4.12.3、Bradycardia

Bradycardia	NO

Bradycardia

5.Follow-up

Postoperative adverse reactions

5.1.

5.5.1.5.1.1、1 day preoperative STAI-S

1 day preoperative STAI-S	21

1 day preoperative STAI-S

5.5.1.5.1.2、Postoperative day STAI-S

Postoperative day STAI-S	20

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	27

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	29

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	30

Postoperative 1-day MMSE

5.3.Postoperative adverse reactions

5.5.3.5.3.1、Nausea

Nausea	NO

Nausea

5.5.3.5.3.2、Vomit

Vomit	NO

Vomit

5.5.3.5.3.3、Dizzy

Dizzy	NO

Dizzy

5.5.3.5.3.4、Headache

Headache

5.5.3.5.3.5、Respiratory suppression

Respiratory suppression