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	68 years old

2.2.Weight

Weight	70 kg

Weight

70 kg

2.3.Height

Height	1.74 m

Height

1.74 m

2.4.BMI

BMI	23.12 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	155 mmHg
Systolic pressure T2	147 mmHg
Systolic pressure T3	135 mmHg
Systolic pressure T4	141 mmHg
Systolic pressure T5	144 mmHg
Systolic pressure T6	128 mmHg
Systolic pressure T7	130 mmHg
Systolic pressure T8	128 mmHg
Systolic pressure T9	125 mmHg
Systolic pressure T10	126 mmHg
Systolic pressure T11	125 mmHg
Systolic pressure T12	138 mmHg
Systolic pressure T13	152 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	67 mmHg
Diastolic pressure T2	69 mmHg
Diastolic pressure T3	69 mmHg
Diastolic pressure T4	71 mmHg
Diastolic pressure T5	71 mmHg
Diastolic pressure T6	66 mmHg
Diastolic pressure T7	66 mmHg
Diastolic pressure T8	62 mmHg
Diastolic pressure T9	61 mmHg
Diastolic pressure T10	59 mmHg
Diastolic pressure T11	67 mmHg
Diastolic pressure T12	66 mmHg
Diastolic pressure T13	68 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	101 mmHg
Mean arterial pressure T2	103 mmHg
Mean arterial pressure T3	91 mmHg
Mean arterial pressure T4	101 mmHg
Mean arterial pressure T5	100 mmHg
Mean arterial pressure T6	87 mmHg
Mean arterial pressure T7	89 mmHg
Mean arterial pressure T8	95 mmHg
Mean arterial pressure T9	88 mmHg
Mean arterial pressure T10	96 mmHg
Mean arterial pressure T11	92 mmHg
Mean arterial pressure T12	90 mmHg
Mean arterial pressure T13	105 mmHg

3.4.Heart rate

Heart rate T1	80 times/min
Heart rate T2	79 times/min
Heart rate T3	75 times/min
Heart rate T4	77 times/min
Heart rate T5	76 times/min
Heart rate T6	70 times/min
Heart rate T7	62 times/min
Heart rate T8	55 times/min
Heart rate T9	54 mmHg
Heart rate T10	52 times/min
Heart rate T11	54 times/min
Heart rate T12	53 times/min
Heart rate T13	56 times/min

3.5.Respiratory rate

Respiratory rate T1	24 times/min
Respiratory rate T2	22 times/min
Respiratory rate T3	21 times/min
Respiratory rate T4	23 times/min
Respiratory rate T5	23 times/min
Respiratory rate T6	18 times/min
Respiratory rate T7	18 times/min
Respiratory rate T8	15 times/min
Respiratory rate T9	17 times/min
Respiratory rate T10	15 times/min
Respiratory rate T11	16 times/min
Respiratory rate T12	17 times/min
Respiratory rate T13	18 times/min

3.6.Oxygen saturation

Oxygen saturation T1	95 %
Oxygen saturation T2	93 %
Oxygen saturation T3	95 %
Oxygen saturation T4	96 %
Oxygen saturation T5	95 %
Oxygen saturation T6	95 %
Oxygen saturation T7	94 %
Oxygen saturation T8	95 %
Oxygen saturation T9	95 %
Oxygen saturation T10	94 %
Oxygen saturation T11	96 %
Oxygen saturation T12	96 %
Oxygen saturation T13	96 %

3.7.BIS

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

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	3

A-VAS

4.6.Operation duration

Operation duration	111 min

Operation duration

111 min

4.7.Time-on

Time-on	11:25

Time-on

11:25

4.8.End time

End time	13:16

End time

13:16

4.9.Departure time

Departure time	13:28

Departure time

13:28

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	29

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