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	73 years old

2.2.Weight

Weight	70 kg

Weight

70 kg

2.3.Height

Height	1.76 m

Height

1.76 m

2.4.BMI

BMI	22.6 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	136 mmHg
Systolic pressure T2	127 mmHg
Systolic pressure T3	124 mmHg
Systolic pressure T4	126 mmHg
Systolic pressure T5	139 mmHg
Systolic pressure T6	129 mmHg
Systolic pressure T7	135 mmHg
Systolic pressure T8	137 mmHg
Systolic pressure T9	133 mmHg
Systolic pressure T10	136 mmHg
Systolic pressure T11	129 mmHg
Systolic pressure T12	131 mmHg
Systolic pressure T13	119 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	78 mmHg
Diastolic pressure T2	74 mmHg
Diastolic pressure T3	75 mmHg
Diastolic pressure T4	68 mmHg
Diastolic pressure T5	74 mmHg
Diastolic pressure T6	71 mmHg
Diastolic pressure T7	77 mmHg
Diastolic pressure T8	74 mmHg
Diastolic pressure T9	80 mmHg
Diastolic pressure T10	78 mmHg
Diastolic pressure T11	73 mmHg
Diastolic pressure T12	72 mmHg
Diastolic pressure T13	69 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	98 mmHg
Mean arterial pressure T2	87 mmHg
Mean arterial pressure T3	84 mmHg
Mean arterial pressure T4	95 mmHg
Mean arterial pressure T5	88 mmHg
Mean arterial pressure T6	84 mmHg
Mean arterial pressure T7	88 mmHg
Mean arterial pressure T8	89 mmHg
Mean arterial pressure T9	94 mmHg
Mean arterial pressure T10	88 mmHg
Mean arterial pressure T11	82 mmHg
Mean arterial pressure T12	83 mmHg
Mean arterial pressure T13	84 mmHg

3.4.Heart rate

Heart rate T1	62 times/min
Heart rate T2	60 times/min
Heart rate T3	57 times/min
Heart rate T4	58 times/min
Heart rate T5	58 times/min
Heart rate T6	55 times/min
Heart rate T7	54 times/min
Heart rate T8	53 times/min
Heart rate T9	54 mmHg
Heart rate T10	51 times/min
Heart rate T11	52 times/min
Heart rate T12	53 times/min
Heart rate T13	53 times/min

3.5.Respiratory rate

Respiratory rate T1	18 times/min
Respiratory rate T2	17 times/min
Respiratory rate T3	20 times/min
Respiratory rate T4	18 times/min
Respiratory rate T5	19 times/min
Respiratory rate T6	17 times/min
Respiratory rate T7	12 times/min
Respiratory rate T8	20 times/min
Respiratory rate T9	14 times/min
Respiratory rate T10	21 times/min
Respiratory rate T11	18 times/min
Respiratory rate T12	13 times/min
Respiratory rate T13	18 times/min

3.6.Oxygen saturation

Oxygen saturation T1	96 %
Oxygen saturation T2	97 %
Oxygen saturation T3	98 %
Oxygen saturation T4	99 %
Oxygen saturation T5	100 %
Oxygen saturation T6	99 %
Oxygen saturation T7	99 %
Oxygen saturation T8	98 %
Oxygen saturation T9	99 %
Oxygen saturation T10	100 %
Oxygen saturation T11	99 %
Oxygen saturation T12	99 %
Oxygen saturation T13	99 %

3.7.BIS

BIS T1	92
BIS T2	90
BIS T3	87
BIS T4	94
BIS T5	86
BIS T6	94
BIS T7	91
BIS T8	86
BIS T9	80
BIS T10	89
BIS T11	92
BIS T12	90
BIS T13	93

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	61 min

Operation duration

61 min

4.7.Time-on

Time-on	08:54

Time-on

08:54

4.8.End time

End time	09:55

End time

09:55

4.9.Departure time

Departure time	10:01

Departure time

10:01

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	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	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