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	60 kg

Weight

60 kg

2.3.Height

Height	1.74 m

Height

1.74 m

2.4.BMI

BMI	19.82 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	140 mmHg
Systolic pressure T2	139 mmHg
Systolic pressure T3	137 mmHg
Systolic pressure T4	133 mmHg
Systolic pressure T5	133 mmHg
Systolic pressure T6	130 mmHg
Systolic pressure T7	123 mmHg
Systolic pressure T8	122 mmHg
Systolic pressure T9	117 mmHg
Systolic pressure T10	116 mmHg
Systolic pressure T11	125 mmHg
Systolic pressure T12	127 mmHg
Systolic pressure T13	115 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	92 mmHg
Diastolic pressure T2	80 mmHg
Diastolic pressure T3	81 mmHg
Diastolic pressure T4	81 mmHg
Diastolic pressure T5	77 mmHg
Diastolic pressure T6	75 mmHg
Diastolic pressure T7	73 mmHg
Diastolic pressure T8	74 mmHg
Diastolic pressure T9	74 mmHg
Diastolic pressure T10	72 mmHg
Diastolic pressure T11	78 mmHg
Diastolic pressure T12	74 mmHg
Diastolic pressure T13	68 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	108 mmHg
Mean arterial pressure T2	99 mmHg
Mean arterial pressure T3	106 mmHg
Mean arterial pressure T4	100 mmHg
Mean arterial pressure T5	92 mmHg
Mean arterial pressure T6	96 mmHg
Mean arterial pressure T7	96 mmHg
Mean arterial pressure T8	87 mmHg
Mean arterial pressure T9	87 mmHg
Mean arterial pressure T10	87 mmHg
Mean arterial pressure T11	91 mmHg
Mean arterial pressure T12	88 mmHg
Mean arterial pressure T13	80 mmHg

3.4.Heart rate

Heart rate T1	78 times/min
Heart rate T2	83 times/min
Heart rate T3	73 times/min
Heart rate T4	69 times/min
Heart rate T5	70 times/min
Heart rate T6	66 times/min
Heart rate T7	61 times/min
Heart rate T8	58 times/min
Heart rate T9	57 mmHg
Heart rate T10	57 times/min
Heart rate T11	58 times/min
Heart rate T12	57 times/min
Heart rate T13	62 times/min

3.5.Respiratory rate

Respiratory rate T1	10 times/min
Respiratory rate T2	14 times/min
Respiratory rate T3	14 times/min
Respiratory rate T4	10 times/min
Respiratory rate T5	11 times/min
Respiratory rate T6	9 times/min
Respiratory rate T7	10 times/min
Respiratory rate T8	10 times/min
Respiratory rate T9	10 times/min
Respiratory rate T10	9 times/min
Respiratory rate T11	10 times/min
Respiratory rate T12	10 times/min
Respiratory rate T13	15 times/min

3.6.Oxygen saturation

Oxygen saturation T1	98 %
Oxygen saturation T2	98 %
Oxygen saturation T3	99 %
Oxygen saturation T4	100 %
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	97
BIS T2	98
BIS T3	96
BIS T4	96
BIS T5	95
BIS T6	88
BIS T7	83
BIS T8	81
BIS T9	84
BIS T10	97
BIS T11	93
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	L3-4

Puncture space

L3-4

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	124 min

Operation duration

124 min

4.7.Time-on

Time-on	14:08

Time-on

14:08

4.8.End time

End time	16:12

End time

16:12

4.9.Departure time

Departure time	16:18

Departure time

16:18

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	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	29

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	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