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	69 years old

2.2.Weight

Weight	72.5 kg

Weight

72.5 kg

2.3.Height

Height	1.72 m

Height

1.72 m

2.4.BMI

BMI	24.51 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	Diabetes

Underlying disease

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	156 mmHg
Systolic pressure T2	152 mmHg
Systolic pressure T3	143 mmHg
Systolic pressure T4	143 mmHg
Systolic pressure T5	154 mmHg
Systolic pressure T6	152 mmHg
Systolic pressure T7	136 mmHg
Systolic pressure T8	137 mmHg
Systolic pressure T9	129 mmHg
Systolic pressure T10	126 mmHg
Systolic pressure T11	122 mmHg
Systolic pressure T12	108 mmHg
Systolic pressure T13	110 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	81 mmHg
Diastolic pressure T2	75 mmHg
Diastolic pressure T3	74 mmHg
Diastolic pressure T4	73 mmHg
Diastolic pressure T5	73 mmHg
Diastolic pressure T6	73 mmHg
Diastolic pressure T7	70 mmHg
Diastolic pressure T8	70 mmHg
Diastolic pressure T9	66 mmHg
Diastolic pressure T10	63 mmHg
Diastolic pressure T11	66 mmHg
Diastolic pressure T12	63 mmHg
Diastolic pressure T13	61 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	106 mmHg
Mean arterial pressure T2	110 mmHg
Mean arterial pressure T3	102 mmHg
Mean arterial pressure T4	104 mmHg
Mean arterial pressure T5	100 mmHg
Mean arterial pressure T6	117 mmHg
Mean arterial pressure T7	103 mmHg
Mean arterial pressure T8	102 mmHg
Mean arterial pressure T9	95 mmHg
Mean arterial pressure T10	88 mmHg
Mean arterial pressure T11	88 mmHg
Mean arterial pressure T12	78 mmHg
Mean arterial pressure T13	71 mmHg

3.4.Heart rate

Heart rate T1	50 times/min
Heart rate T2	53 times/min
Heart rate T3	48 times/min
Heart rate T4	43 times/min
Heart rate T5	45 times/min
Heart rate T6	42 times/min
Heart rate T7	44 times/min
Heart rate T8	44 times/min
Heart rate T9	43 mmHg
Heart rate T10	44 times/min
Heart rate T11	43 times/min
Heart rate T12	48 times/min
Heart rate T13	45 times/min

3.5.Respiratory rate

Respiratory rate T1	12 times/min
Respiratory rate T2	12 times/min
Respiratory rate T3	12 times/min
Respiratory rate T4	16 times/min
Respiratory rate T5	12 times/min
Respiratory rate T6	144 times/min
Respiratory rate T7	14 times/min
Respiratory rate T8	16 times/min
Respiratory rate T9	14 times/min
Respiratory rate T10	19 times/min
Respiratory rate T11	14 times/min
Respiratory rate T12	14 times/min
Respiratory rate T13	14 times/min

3.6.Oxygen saturation

Oxygen saturation T1	99 %
Oxygen saturation T2	100 %
Oxygen saturation T3	100 %
Oxygen saturation T4	100 %
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	96 %
Oxygen saturation T13	97 %

3.7.BIS

BIS T1	98
BIS T2	98
BIS T3	97
BIS T4	98
BIS T5	97
BIS T6	91
BIS T7	65
BIS T8	48
BIS T9	54
BIS T10	45
BIS T11	86
BIS T12	95
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	98

Puncture space

4.2.Dosage of ropivacaine

Dosage of ropivacaine	17 mg

Dosage of ropivacaine

17 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	90 min

Operation duration

90 min

4.7.Time-on

Time-on	12:40

Time-on

12:40

4.8.End time

End time	14:10

End time

14:10

4.9.Departure time

Departure time	14:15

Departure time

14:15

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	45.675 mg

Total dosage of dexmedetomidine

45.675 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	22

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	26

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	25

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