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	66 years old

2.2.Weight

Weight	80 kg

Weight

80 kg

2.3.Height

Height	1.72 m

Height

1.72 m

2.4.BMI

BMI	27.04 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	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	157 mmHg
Systolic pressure T2	156 mmHg
Systolic pressure T3	149 mmHg
Systolic pressure T4	145 mmHg
Systolic pressure T5	149 mmHg
Systolic pressure T6	141 mmHg
Systolic pressure T7	128 mmHg
Systolic pressure T8	131 mmHg
Systolic pressure T9	138 mmHg
Systolic pressure T10	134 mmHg
Systolic pressure T11	139 mmHg
Systolic pressure T12	139 mmHg
Systolic pressure T13	133 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	85 mmHg
Diastolic pressure T2	79 mmHg
Diastolic pressure T3	95 mmHg
Diastolic pressure T4	82 mmHg
Diastolic pressure T5	85 mmHg
Diastolic pressure T6	72 mmHg
Diastolic pressure T7	74 mmHg
Diastolic pressure T8	74 mmHg
Diastolic pressure T9	79 mmHg
Diastolic pressure T10	72 mmHg
Diastolic pressure T11	75 mmHg
Diastolic pressure T12	87 mmHg
Diastolic pressure T13	70 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	129 mmHg
Mean arterial pressure T2	128 mmHg
Mean arterial pressure T3	122 mmHg
Mean arterial pressure T4	114 mmHg
Mean arterial pressure T5	106 mmHg
Mean arterial pressure T6	110 mmHg
Mean arterial pressure T7	102 mmHg
Mean arterial pressure T8	98 mmHg
Mean arterial pressure T9	111 mmHg
Mean arterial pressure T10	92 mmHg
Mean arterial pressure T11	96 mmHg
Mean arterial pressure T12	104 mmHg
Mean arterial pressure T13	91 mmHg

3.4.Heart rate

Heart rate T1	70 times/min
Heart rate T2	68 times/min
Heart rate T3	73 times/min
Heart rate T4	70 times/min
Heart rate T5	72 times/min
Heart rate T6	63 times/min
Heart rate T7	60 times/min
Heart rate T8	61 times/min
Heart rate T9	63 mmHg
Heart rate T10	60 times/min
Heart rate T11	60 times/min
Heart rate T12	62 times/min
Heart rate T13	67 times/min

3.5.Respiratory rate

Respiratory rate T1	18 times/min
Respiratory rate T2	15 times/min
Respiratory rate T3	16 times/min
Respiratory rate T4	13 times/min
Respiratory rate T5	13 times/min
Respiratory rate T6	13 times/min
Respiratory rate T7	18 times/min
Respiratory rate T8	19 times/min
Respiratory rate T9	16 times/min
Respiratory rate T10	20 times/min
Respiratory rate T11	11 times/min
Respiratory rate T12	12 times/min
Respiratory rate T13	16 times/min

3.6.Oxygen saturation

Oxygen saturation T1	96 %
Oxygen saturation T2	98 %
Oxygen saturation T3	97 %
Oxygen saturation T4	97 %
Oxygen saturation T5	96 %
Oxygen saturation T6	95 %
Oxygen saturation T7	96 %
Oxygen saturation T8	95 %
Oxygen saturation T9	95 %
Oxygen saturation T10	95 %
Oxygen saturation T11	96 %
Oxygen saturation T12	95 %
Oxygen saturation T13	97 %

3.7.BIS

BIS T1	97
BIS T2	96
BIS T3	98
BIS T4	98
BIS T5	94
BIS T6	96
BIS T7	96
BIS T8	89
BIS T9	93
BIS T10	98
BIS T11	96
BIS T12	93
BIS T13	97

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	3

A-VAS

4.6.Operation duration

Operation duration	60 min

Operation duration

60 min

4.7.Time-on

Time-on	08:40

Time-on

08:40

4.8.End time

End time	09:40

End time

09:40

4.9.Departure time

Departure time	09:54

Departure time

09:54

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	26

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	24

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