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	79 years old

2.2.Weight

Weight	70 kg

Weight

70 kg

2.3.Height

Height	1.72 m

Height

1.72 m

2.4.BMI

BMI	23.66 kg/m2

2.5.Degree of education

Degree of education	Middle school

Degree of education

Middle school

2.6.ASA

ASA	Ⅲ

ASA

Ⅲ

2.7.Underlying disease

Underlying disease	Hypertention / Diabetes

Underlying disease

Hypertention

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	153 mmHg
Systolic pressure T2	146 mmHg
Systolic pressure T3	130 mmHg
Systolic pressure T4	144 mmHg
Systolic pressure T5	155 mmHg
Systolic pressure T6	134 mmHg
Systolic pressure T7	160 mmHg
Systolic pressure T8	165 mmHg
Systolic pressure T9	160 mmHg
Systolic pressure T10	162 mmHg
Systolic pressure T11	142 mmHg
Systolic pressure T12	139 mmHg
Systolic pressure T13	144 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	89 mmHg
Diastolic pressure T2	79 mmHg
Diastolic pressure T3	82 mmHg
Diastolic pressure T4	85 mmHg
Diastolic pressure T5	88 mmHg
Diastolic pressure T6	77 mmHg
Diastolic pressure T7	98 mmHg
Diastolic pressure T8	94 mmHg
Diastolic pressure T9	99 mmHg
Diastolic pressure T10	87 mmHg
Diastolic pressure T11	90 mmHg
Diastolic pressure T12	90 mmHg
Diastolic pressure T13	86 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	110 mmHg
Mean arterial pressure T2	119 mmHg
Mean arterial pressure T3	93 mmHg
Mean arterial pressure T4	103 mmHg
Mean arterial pressure T5	105 mmHg
Mean arterial pressure T6	96 mmHg
Mean arterial pressure T7	109 mmHg
Mean arterial pressure T8	111 mmHg
Mean arterial pressure T9	113 mmHg
Mean arterial pressure T10	112 mmHg
Mean arterial pressure T11	103 mmHg
Mean arterial pressure T12	103 mmHg
Mean arterial pressure T13	96 mmHg

3.4.Heart rate

Heart rate T1	68 times/min
Heart rate T2	70 times/min
Heart rate T3	71 times/min
Heart rate T4	71 times/min
Heart rate T5	71 times/min
Heart rate T6	72 times/min
Heart rate T7	74 times/min
Heart rate T8	75 times/min
Heart rate T9	72 mmHg
Heart rate T10	73 times/min
Heart rate T11	73 times/min
Heart rate T12	73 times/min
Heart rate T13	76 times/min

3.5.Respiratory rate

Respiratory rate T1	20 times/min
Respiratory rate T2	18 times/min
Respiratory rate T3	21 times/min
Respiratory rate T4	18 times/min
Respiratory rate T5	23 times/min
Respiratory rate T6	20 times/min
Respiratory rate T7	21 times/min
Respiratory rate T8	16 times/min
Respiratory rate T9	18 times/min
Respiratory rate T10	24 times/min
Respiratory rate T11	25 times/min
Respiratory rate T12	17 times/min
Respiratory rate T13	25 times/min

3.6.Oxygen saturation

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

3.7.BIS

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

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	81 min

Operation duration

81 min

4.7.Time-on

Time-on	13:30

Time-on

13:30

4.8.End time

End time	14:51

End time

14:51

4.9.Departure time

Departure time	14:57

Departure time

14:57

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	24

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