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	71 years old

2.2.Weight

Weight	62 kg

Weight

62 kg

2.3.Height

Height	1.72 m

Height

1.72 m

2.4.BMI

BMI	21.6 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	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	149 mmHg
Systolic pressure T2	150 mmHg
Systolic pressure T3	151 mmHg
Systolic pressure T4	149 mmHg
Systolic pressure T5	141 mmHg
Systolic pressure T6	117 mmHg
Systolic pressure T7	111 mmHg
Systolic pressure T8	107 mmHg
Systolic pressure T9	97 mmHg
Systolic pressure T10	90 mmHg
Systolic pressure T11	101 mmHg
Systolic pressure T12	100 mmHg
Systolic pressure T13	105 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	69 mmHg
Diastolic pressure T2	70 mmHg
Diastolic pressure T3	83 mmHg
Diastolic pressure T4	86 mmHg
Diastolic pressure T5	82 mmHg
Diastolic pressure T6	70 mmHg
Diastolic pressure T7	70 mmHg
Diastolic pressure T8	66 mmHg
Diastolic pressure T9	58 mmHg
Diastolic pressure T10	60 mmHg
Diastolic pressure T11	78 mmHg
Diastolic pressure T12	80 mmHg
Diastolic pressure T13	79 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	96 mmHg
Mean arterial pressure T2	97 mmHg
Mean arterial pressure T3	104 mmHg
Mean arterial pressure T4	106 mmHg
Mean arterial pressure T5	106 mmHg
Mean arterial pressure T6	85 mmHg
Mean arterial pressure T7	79 mmHg
Mean arterial pressure T8	77 mmHg
Mean arterial pressure T9	65 mmHg
Mean arterial pressure T10	65 mmHg
Mean arterial pressure T11	86 mmHg
Mean arterial pressure T12	87 mmHg
Mean arterial pressure T13	88 mmHg

3.4.Heart rate

Heart rate T1	53 times/min
Heart rate T2	58 times/min
Heart rate T3	54 times/min
Heart rate T4	52 times/min
Heart rate T5	52 times/min
Heart rate T6	47 times/min
Heart rate T7	46 times/min
Heart rate T8	45 times/min
Heart rate T9	44 mmHg
Heart rate T10	50 times/min
Heart rate T11	52 times/min
Heart rate T12	56 times/min
Heart rate T13	54 times/min

3.5.Respiratory rate

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

3.6.Oxygen saturation

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

3.7.BIS

BIS T1	94
BIS T2	95
BIS T3	93
BIS T4	98
BIS T5	92
BIS T6	90
BIS T7	46
BIS T8	45
BIS T9	47
BIS T10	48
BIS T11	84
BIS T12	85
BIS T13	92

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	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	103 min

Operation duration

103 min

4.7.Time-on

Time-on	12:17

Time-on

12:17

4.8.End time

End time	14:00

End time

14:00

4.9.Departure time

Departure time	14:20

Departure time

14:20

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	40.92 mg

Total dosage of dexmedetomidine

40.92 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	YES

Bradycardia

YES

5.Follow-up

Postoperative adverse reactions

5.1.

5.5.1.5.1.1、1 day preoperative STAI-S

1 day preoperative STAI-S	20

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	29

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	29

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