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	72 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	132 mmHg
Systolic pressure T2	122 mmHg
Systolic pressure T3	120 mmHg
Systolic pressure T4	115 mmHg
Systolic pressure T5	116 mmHg
Systolic pressure T6	113 mmHg
Systolic pressure T7	116 mmHg
Systolic pressure T8	119 mmHg
Systolic pressure T9	121 mmHg
Systolic pressure T10	120 mmHg
Systolic pressure T11	123 mmHg
Systolic pressure T12	118 mmHg
Systolic pressure T13	119 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	74 mmHg
Diastolic pressure T2	66 mmHg
Diastolic pressure T3	72 mmHg
Diastolic pressure T4	71 mmHg
Diastolic pressure T5	67 mmHg
Diastolic pressure T6	69 mmHg
Diastolic pressure T7	64 mmHg
Diastolic pressure T8	63 mmHg
Diastolic pressure T9	64 mmHg
Diastolic pressure T10	70 mmHg
Diastolic pressure T11	75 mmHg
Diastolic pressure T12	70 mmHg
Diastolic pressure T13	72 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	94 mmHg
Mean arterial pressure T2	98 mmHg
Mean arterial pressure T3	93 mmHg
Mean arterial pressure T4	89 mmHg
Mean arterial pressure T5	90 mmHg
Mean arterial pressure T6	88 mmHg
Mean arterial pressure T7	90 mmHg
Mean arterial pressure T8	81 mmHg
Mean arterial pressure T9	89 mmHg
Mean arterial pressure T10	81 mmHg
Mean arterial pressure T11	91 mmHg
Mean arterial pressure T12	86 mmHg
Mean arterial pressure T13	87 mmHg

3.4.Heart rate

Heart rate T1	49 times/min
Heart rate T2	59 times/min
Heart rate T3	48 times/min
Heart rate T4	48 times/min
Heart rate T5	48 times/min
Heart rate T6	47 times/min
Heart rate T7	48 times/min
Heart rate T8	49 times/min
Heart rate T9	51 mmHg
Heart rate T10	55 times/min
Heart rate T11	57 times/min
Heart rate T12	60 times/min
Heart rate T13	59 times/min

3.5.Respiratory rate

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

3.6.Oxygen saturation

Oxygen saturation T1	99 %
Oxygen saturation T2	99 %
Oxygen saturation T3	99 %
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	98
BIS T2	98
BIS T3	98
BIS T4	98
BIS T5	98
BIS T6	95
BIS T7	97
BIS T8	77
BIS T9	77
BIS T10	74
BIS T11	88
BIS T12	92
BIS T13	91

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	T8

Sensory blockade plane

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	63 min

Operation duration

63 min

4.7.Time-on

Time-on	10:12

Time-on

10:12

4.8.End time

End time	11:15

End time

11:15

4.9.Departure time

Departure time	11:25

Departure time

11:25

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	YES

Bradycardia

YES

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	28

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