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	77 years old

2.2.Weight

Weight	70 kg

Weight

70 kg

2.3.Height

Height	1.70 m

Height

1.70 m

2.4.BMI

BMI	24.22 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	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	176 mmHg
Systolic pressure T2	163 mmHg
Systolic pressure T3	155 mmHg
Systolic pressure T4	152 mmHg
Systolic pressure T5	156 mmHg
Systolic pressure T6	149 mmHg
Systolic pressure T7	157 mmHg
Systolic pressure T8	147 mmHg
Systolic pressure T9	144 mmHg
Systolic pressure T10	158 mmHg
Systolic pressure T11	150 mmHg
Systolic pressure T12	150 mmHg
Systolic pressure T13	160 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	88 mmHg
Diastolic pressure T2	75 mmHg
Diastolic pressure T3	72 mmHg
Diastolic pressure T4	73 mmHg
Diastolic pressure T5	74 mmHg
Diastolic pressure T6	72 mmHg
Diastolic pressure T7	71 mmHg
Diastolic pressure T8	79 mmHg
Diastolic pressure T9	69 mmHg
Diastolic pressure T10	70 mmHg
Diastolic pressure T11	76 mmHg
Diastolic pressure T12	71 mmHg
Diastolic pressure T13	74 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	108 mmHg
Mean arterial pressure T2	104 mmHg
Mean arterial pressure T3	99 mmHg
Mean arterial pressure T4	99 mmHg
Mean arterial pressure T5	101 mmHg
Mean arterial pressure T6	97 mmHg
Mean arterial pressure T7	99 mmHg
Mean arterial pressure T8	92 mmHg
Mean arterial pressure T9	94 mmHg
Mean arterial pressure T10	80 mmHg
Mean arterial pressure T11	87 mmHg
Mean arterial pressure T12	80 mmHg
Mean arterial pressure T13	87 mmHg

3.4.Heart rate

Heart rate T1	65 times/min
Heart rate T2	67 times/min
Heart rate T3	56 times/min
Heart rate T4	54 times/min
Heart rate T5	54 times/min
Heart rate T6	51 times/min
Heart rate T7	51 times/min
Heart rate T8	57 times/min
Heart rate T9	52 mmHg
Heart rate T10	50 times/min
Heart rate T11	51 times/min
Heart rate T12	56 times/min
Heart rate T13	58 times/min

3.5.Respiratory rate

Respiratory rate T1	12 times/min
Respiratory rate T2	12 times/min
Respiratory rate T3	10 times/min
Respiratory rate T4	11 times/min
Respiratory rate T5	11 times/min
Respiratory rate T6	14 times/min
Respiratory rate T7	17 times/min
Respiratory rate T8	14 times/min
Respiratory rate T9	13 times/min
Respiratory rate T10	11 times/min
Respiratory rate T11	9 times/min
Respiratory rate T12	11 times/min
Respiratory rate T13	11 times/min

3.6.Oxygen saturation

Oxygen saturation T1	99 %
Oxygen saturation T2	94 %
Oxygen saturation T3	96 %
Oxygen saturation T4	98 %
Oxygen saturation T5	99 %
Oxygen saturation T6	99 %
Oxygen saturation T7	99 %
Oxygen saturation T8	100 %
Oxygen saturation T9	99 %
Oxygen saturation T10	99 %
Oxygen saturation T11	100 %
Oxygen saturation T12	96 %
Oxygen saturation T13	96 %

3.7.BIS

BIS T1	91
BIS T2	94
BIS T3	86
BIS T4	91
BIS T5	88
BIS T6	90
BIS T7	95
BIS T8	69
BIS T9	80
BIS T10	68
BIS T11	88
BIS T12	95
BIS T13	90

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	54 min

Operation duration

54 min

4.7.Time-on

Time-on	12:33

Time-on

12:33

4.8.End time

End time	13:27

End time

13:27

4.9.Departure time

Departure time	13:33

Departure time

13:33

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	23

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	26

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