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
Intraoperative use of other sedative drugs	NO
Change the anesthesia method to general anesthesia for patients	NO
Patients transferred to ICU after surgery	NO

2.Baseline

Age
Weight
Height
BMI
Degree of education
ASA
Underlying disease

2.1.Age

Age	77 years old

2.2.Weight

Weight	60 kg

Weight

60 kg

2.3.Height

Height	1.60 m

Height

1.60 m

2.4.BMI

BMI	23.44 kg/m2

2.5.Degree of education

Degree of education	Primary school

Degree of education

Primary school

2.6.ASA

ASA	Ⅱ

ASA

Ⅱ

2.7.Underlying disease

Underlying disease	None

Underlying disease

None

3.Intraoperative indicators

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

3.1.Systolic pressure

Systolic pressure T1	151 mmHg
Systolic pressure T2	141 mmHg
Systolic pressure T3	131 mmHg
Systolic pressure T4	137 mmHg
Systolic pressure T5	137 mmHg
Systolic pressure T6	130 mmHg
Systolic pressure T7	131 mmHg
Systolic pressure T8	124 mmHg
Systolic pressure T9	126 mmHg
Systolic pressure T10	133 mmHg
Systolic pressure T11	133 mmHg
Systolic pressure T12	136 mmHg
Systolic pressure T13	118 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	76 mmHg
Diastolic pressure T2	72 mmHg
Diastolic pressure T3	72 mmHg
Diastolic pressure T4	76 mmHg
Diastolic pressure T5	76 mmHg
Diastolic pressure T6	73 mmHg
Diastolic pressure T7	76 mmHg
Diastolic pressure T8	72 mmHg
Diastolic pressure T9	77 mmHg
Diastolic pressure T10	74 mmHg
Diastolic pressure T11	73 mmHg
Diastolic pressure T12	74 mmHg
Diastolic pressure T13	68 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	113 mmHg
Mean arterial pressure T2	95 mmHg
Mean arterial pressure T3	91 mmHg
Mean arterial pressure T4	83 mmHg
Mean arterial pressure T5	83 mmHg
Mean arterial pressure T6	103 mmHg
Mean arterial pressure T7	106 mmHg
Mean arterial pressure T8	101 mmHg
Mean arterial pressure T9	100 mmHg
Mean arterial pressure T10	105 mmHg
Mean arterial pressure T11	93 mmHg
Mean arterial pressure T12	94 mmHg
Mean arterial pressure T13	96 mmHg

3.4.Heart rate

Heart rate T1	72 times/min
Heart rate T2	76 times/min
Heart rate T3	77 times/min
Heart rate T4	73 times/min
Heart rate T5	73 times/min
Heart rate T6	66 times/min
Heart rate T7	63 times/min
Heart rate T8	60 times/min
Heart rate T9	60 mmHg
Heart rate T10	60 times/min
Heart rate T11	60 times/min
Heart rate T12	60 times/min
Heart rate T13	62 times/min

3.5.Respiratory rate

Respiratory rate T1	16 times/min
Respiratory rate T2	20 times/min
Respiratory rate T3	21 times/min
Respiratory rate T4	14 times/min
Respiratory rate T5	14 times/min
Respiratory rate T6	18 times/min
Respiratory rate T7	15 times/min
Respiratory rate T8	13 times/min
Respiratory rate T9	15 times/min
Respiratory rate T10	9 times/min
Respiratory rate T11	11 times/min
Respiratory rate T12	10 times/min
Respiratory rate T13	12 times/min

3.6.Oxygen saturation

Oxygen saturation T1	97 %
Oxygen saturation T2	96 %
Oxygen saturation T3	97 %
Oxygen saturation T4	97 %
Oxygen saturation T5	97 %
Oxygen saturation T6	95 %
Oxygen saturation T7	96 %
Oxygen saturation T8	97 %
Oxygen saturation T9	97 %
Oxygen saturation T10	99 %
Oxygen saturation T11	94 %
Oxygen saturation T12	95 %
Oxygen saturation T13	96 %

3.7.BIS

BIS T1	98
BIS T2	96
BIS T3	97
BIS T4	96
BIS T5	97
BIS T6	94
BIS T7	97
BIS T8	97
BIS T9	96
BIS T10	98
BIS T11	98
BIS T12	98
BIS T13	96

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	18 mg

Dosage of ropivacaine

18 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	62 min

Operation duration

62 min

4.7.Time-on

Time-on	11:33

Time-on

11:33

4.8.End time

End time	12:35

End time

12:35

4.9.Departure time

Departure time	12:43

Departure time

12:43

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	20

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	26

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	29

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