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	69 years old

2.2.Weight

Weight	65 kg

Weight

65 kg

2.3.Height

Height	1.70 m

Height

1.70 m

2.4.BMI

BMI	22.49 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	152 mmHg
Systolic pressure T2	144 mmHg
Systolic pressure T3	139 mmHg
Systolic pressure T4	149 mmHg
Systolic pressure T5	147 mmHg
Systolic pressure T6	142 mmHg
Systolic pressure T7	140 mmHg
Systolic pressure T8	132 mmHg
Systolic pressure T9	135 mmHg
Systolic pressure T10	138 mmHg
Systolic pressure T11	130 mmHg
Systolic pressure T12	124 mmHg
Systolic pressure T13	122 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	77 mmHg
Diastolic pressure T2	87 mmHg
Diastolic pressure T3	82 mmHg
Diastolic pressure T4	87 mmHg
Diastolic pressure T5	89 mmHg
Diastolic pressure T6	83 mmHg
Diastolic pressure T7	82 mmHg
Diastolic pressure T8	87 mmHg
Diastolic pressure T9	80 mmHg
Diastolic pressure T10	81 mmHg
Diastolic pressure T11	80 mmHg
Diastolic pressure T12	83 mmHg
Diastolic pressure T13	76 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	102 mmHg
Mean arterial pressure T2	103 mmHg
Mean arterial pressure T3	111 mmHg
Mean arterial pressure T4	120 mmHg
Mean arterial pressure T5	115 mmHg
Mean arterial pressure T6	115 mmHg
Mean arterial pressure T7	112 mmHg
Mean arterial pressure T8	106 mmHg
Mean arterial pressure T9	108 mmHg
Mean arterial pressure T10	103 mmHg
Mean arterial pressure T11	93 mmHg
Mean arterial pressure T12	94 mmHg
Mean arterial pressure T13	91 mmHg

3.4.Heart rate

Heart rate T1	74 times/min
Heart rate T2	70 times/min
Heart rate T3	72 times/min
Heart rate T4	67 times/min
Heart rate T5	68 times/min
Heart rate T6	66 times/min
Heart rate T7	62 times/min
Heart rate T8	61 times/min
Heart rate T9	58 mmHg
Heart rate T10	59 times/min
Heart rate T11	93 times/min
Heart rate T12	93 times/min
Heart rate T13	94 times/min

3.5.Respiratory rate

Respiratory rate T1	18 times/min
Respiratory rate T2	18 times/min
Respiratory rate T3	21 times/min
Respiratory rate T4	17 times/min
Respiratory rate T5	15 times/min
Respiratory rate T6	14 times/min
Respiratory rate T7	15 times/min
Respiratory rate T8	17 times/min
Respiratory rate T9	21 times/min
Respiratory rate T10	28 times/min
Respiratory rate T11	19 times/min
Respiratory rate T12	17 times/min
Respiratory rate T13	17 times/min

3.6.Oxygen saturation

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

3.7.BIS

BIS T1	96
BIS T2	98
BIS T3	97
BIS T4	97
BIS T5	98
BIS T6	96
BIS T7	90
BIS T8	91
BIS T9	87
BIS T10	91
BIS T11	92
BIS T12	90
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	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	144 min

Operation duration

144 min

4.7.Time-on

Time-on	15:42

Time-on

15:42

4.8.End time

End time	18:06

End time

18:06

4.9.Departure time

Departure time	18:12

Departure time

18:12

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	21

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	23

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	28

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