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	84 years old

2.2.Weight

Weight	63 kg

Weight

63 kg

2.3.Height

Height	1.78 m

Height

1.78 m

2.4.BMI

BMI	19.88 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	154 mmHg
Systolic pressure T3	150 mmHg
Systolic pressure T4	150 mmHg
Systolic pressure T5	153 mmHg
Systolic pressure T6	148 mmHg
Systolic pressure T7	154 mmHg
Systolic pressure T8	148 mmHg
Systolic pressure T9	157 mmHg
Systolic pressure T10	158 mmHg
Systolic pressure T11	159 mmHg
Systolic pressure T12	156 mmHg
Systolic pressure T13	161 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	112 mmHg
Diastolic pressure T2	90 mmHg
Diastolic pressure T3	86 mmHg
Diastolic pressure T4	84 mmHg
Diastolic pressure T5	87 mmHg
Diastolic pressure T6	86 mmHg
Diastolic pressure T7	88 mmHg
Diastolic pressure T8	87 mmHg
Diastolic pressure T9	89 mmHg
Diastolic pressure T10	88 mmHg
Diastolic pressure T11	97 mmHg
Diastolic pressure T12	91 mmHg
Diastolic pressure T13	89 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	116 mmHg
Mean arterial pressure T2	113 mmHg
Mean arterial pressure T3	119 mmHg
Mean arterial pressure T4	106 mmHg
Mean arterial pressure T5	103 mmHg
Mean arterial pressure T6	109 mmHg
Mean arterial pressure T7	106 mmHg
Mean arterial pressure T8	101 mmHg
Mean arterial pressure T9	115 mmHg
Mean arterial pressure T10	112 mmHg
Mean arterial pressure T11	117 mmHg
Mean arterial pressure T12	121 mmHg
Mean arterial pressure T13	113 mmHg

3.4.Heart rate

Heart rate T1	77 times/min
Heart rate T2	76 times/min
Heart rate T3	78 times/min
Heart rate T4	75 times/min
Heart rate T5	74 times/min
Heart rate T6	73 times/min
Heart rate T7	72 times/min
Heart rate T8	71 times/min
Heart rate T9	71 mmHg
Heart rate T10	71 times/min
Heart rate T11	72 times/min
Heart rate T12	72 times/min
Heart rate T13	74 times/min

3.5.Respiratory rate

Respiratory rate T1	20 times/min
Respiratory rate T2	16 times/min
Respiratory rate T3	25 times/min
Respiratory rate T4	17 times/min
Respiratory rate T5	18 times/min
Respiratory rate T6	16 times/min
Respiratory rate T7	18 times/min
Respiratory rate T8	19 times/min
Respiratory rate T9	18 times/min
Respiratory rate T10	16 times/min
Respiratory rate T11	16 times/min
Respiratory rate T12	18 times/min
Respiratory rate T13	19 times/min

3.6.Oxygen saturation

Oxygen saturation T1	94 %
Oxygen saturation T2	95 %
Oxygen saturation T3	95 %
Oxygen saturation T4	97 %
Oxygen saturation T5	98 %
Oxygen saturation T6	98 %
Oxygen saturation T7	95 %
Oxygen saturation T8	98 %
Oxygen saturation T9	95 %
Oxygen saturation T10	98 %
Oxygen saturation T11	97 %
Oxygen saturation T12	96 %
Oxygen saturation T13	96 %

3.7.BIS

BIS T1	96
BIS T2	93
BIS T3	97
BIS T4	95
BIS T5	92
BIS T6	95
BIS T7	94
BIS T8	98
BIS T9	87
BIS T10	82
BIS T11	96
BIS T12	97
BIS T13	98

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	20 mg

Dosage of ropivacaine

20 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	186 min

Operation duration

186 min

4.7.Time-on

Time-on	10:35

Time-on

10:35

4.8.End time

End time	13:41

End time

13:41

4.9.Departure time

Departure time	13:47

Departure time

13:47

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	25

1 day preoperative STAI-S

5.5.1.5.1.2、Postoperative day STAI-S

Postoperative day STAI-S	21

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	22

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	27

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