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	77 years old

2.2.Weight

Weight	77.5 kg

Weight

77.5 kg

2.3.Height

Height	1.75 m

Height

1.75 m

2.4.BMI

BMI	25.31 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	Other

Underlying disease

Other

3.Intraoperative indicators

Systolic pressure
Diastolic pressure
Mean arterial pressure
Heart rate
Respiratory rate
Oxygen saturation
BIS

3.1.Systolic pressure

Systolic pressure T1	174 mmHg
Systolic pressure T2	170 mmHg
Systolic pressure T3	175 mmHg
Systolic pressure T4	177 mmHg
Systolic pressure T5	173 mmHg
Systolic pressure T6	168 mmHg
Systolic pressure T7	167 mmHg
Systolic pressure T8	164 mmHg
Systolic pressure T9	169 mmHg
Systolic pressure T10	181 mmHg
Systolic pressure T11	187 mmHg
Systolic pressure T12	166 mmHg
Systolic pressure T13	187 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	92 mmHg
Diastolic pressure T2	89 mmHg
Diastolic pressure T3	99 mmHg
Diastolic pressure T4	100 mmHg
Diastolic pressure T5	96 mmHg
Diastolic pressure T6	95 mmHg
Diastolic pressure T7	97 mmHg
Diastolic pressure T8	96 mmHg
Diastolic pressure T9	97 mmHg
Diastolic pressure T10	102 mmHg
Diastolic pressure T11	104 mmHg
Diastolic pressure T12	105 mmHg
Diastolic pressure T13	108 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	119 mmHg
Mean arterial pressure T2	139 mmHg
Mean arterial pressure T3	134 mmHg
Mean arterial pressure T4	134 mmHg
Mean arterial pressure T5	136 mmHg
Mean arterial pressure T6	119 mmHg
Mean arterial pressure T7	125 mmHg
Mean arterial pressure T8	127 mmHg
Mean arterial pressure T9	130 mmHg
Mean arterial pressure T10	128 mmHg
Mean arterial pressure T11	133 mmHg
Mean arterial pressure T12	125 mmHg
Mean arterial pressure T13	134 mmHg

3.4.Heart rate

Heart rate T1	73 times/min
Heart rate T2	72 times/min
Heart rate T3	70 times/min
Heart rate T4	67 times/min
Heart rate T5	67 times/min
Heart rate T6	65 times/min
Heart rate T7	65 times/min
Heart rate T8	66 times/min
Heart rate T9	66 mmHg
Heart rate T10	65 times/min
Heart rate T11	64 times/min
Heart rate T12	75 times/min
Heart rate T13	71 times/min

3.5.Respiratory rate

Respiratory rate T1	12 times/min
Respiratory rate T2	16 times/min
Respiratory rate T3	12 times/min
Respiratory rate T4	13 times/min
Respiratory rate T5	13 times/min
Respiratory rate T6	15 times/min
Respiratory rate T7	15 times/min
Respiratory rate T8	16 times/min
Respiratory rate T9	17 times/min
Respiratory rate T10	22 times/min
Respiratory rate T11	13 times/min
Respiratory rate T12	12 times/min
Respiratory rate T13	14 times/min

3.6.Oxygen saturation

Oxygen saturation T1	95 %
Oxygen saturation T2	95 %
Oxygen saturation T3	96 %
Oxygen saturation T4	97 %
Oxygen saturation T5	97 %
Oxygen saturation T6	97 %
Oxygen saturation T7	97 %
Oxygen saturation T8	99 %
Oxygen saturation T9	99 %
Oxygen saturation T10	99 %
Oxygen saturation T11	100 %
Oxygen saturation T12	98 %
Oxygen saturation T13	98 %

3.7.BIS

BIS T1	88
BIS T2	92
BIS T3	95
BIS T4	86
BIS T5	94
BIS T6	68
BIS T7	86
BIS T8	77
BIS T9	90
BIS T10	61
BIS T11	96
BIS T12	98
BIS T13	97

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	78 min

Operation duration

78 min

4.7.Time-on

Time-on	08:55

Time-on

08:55

4.8.End time

End time	10:13

End time

10:13

4.9.Departure time

Departure time	10:19

Departure time

10:19

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	30

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	30

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