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	62 years old

2.2.Weight

Weight	85 kg

Weight

85 kg

2.3.Height

Height	1.77 m

Height

1.77 m

2.4.BMI

BMI	27.13 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	146 mmHg
Systolic pressure T2	147 mmHg
Systolic pressure T3	141 mmHg
Systolic pressure T4	144 mmHg
Systolic pressure T5	137 mmHg
Systolic pressure T6	126 mmHg
Systolic pressure T7	122 mmHg
Systolic pressure T8	119 mmHg
Systolic pressure T9	116 mmHg
Systolic pressure T10	133 mmHg
Systolic pressure T11	131 mmHg
Systolic pressure T12	131 mmHg
Systolic pressure T13	117 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	111 mmHg
Diastolic pressure T2	107 mmHg
Diastolic pressure T3	110 mmHg
Diastolic pressure T4	114 mmHg
Diastolic pressure T5	108 mmHg
Diastolic pressure T6	96 mmHg
Diastolic pressure T7	91 mmHg
Diastolic pressure T8	91 mmHg
Diastolic pressure T9	90 mmHg
Diastolic pressure T10	89 mmHg
Diastolic pressure T11	99 mmHg
Diastolic pressure T12	107 mmHg
Diastolic pressure T13	95 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	111 mmHg
Mean arterial pressure T2	107 mmHg
Mean arterial pressure T3	110 mmHg
Mean arterial pressure T4	114 mmHg
Mean arterial pressure T5	108 mmHg
Mean arterial pressure T6	96 mmHg
Mean arterial pressure T7	91 mmHg
Mean arterial pressure T8	91 mmHg
Mean arterial pressure T9	90 mmHg
Mean arterial pressure T10	89 mmHg
Mean arterial pressure T11	99 mmHg
Mean arterial pressure T12	107 mmHg
Mean arterial pressure T13	95 mmHg

3.4.Heart rate

Heart rate T1	86 times/min
Heart rate T2	83 times/min
Heart rate T3	83 times/min
Heart rate T4	73 times/min
Heart rate T5	70 times/min
Heart rate T6	65 times/min
Heart rate T7	64 times/min
Heart rate T8	65 times/min
Heart rate T9	63 mmHg
Heart rate T10	66 times/min
Heart rate T11	61 times/min
Heart rate T12	62 times/min
Heart rate T13	63 times/min

3.5.Respiratory rate

Respiratory rate T1	14 times/min
Respiratory rate T2	22 times/min
Respiratory rate T3	15 times/min
Respiratory rate T4	13 times/min
Respiratory rate T5	14 times/min
Respiratory rate T6	16 times/min
Respiratory rate T7	16 times/min
Respiratory rate T8	17 times/min
Respiratory rate T9	17 times/min
Respiratory rate T10	22 times/min
Respiratory rate T11	11 times/min
Respiratory rate T12	12 times/min
Respiratory rate T13	12 times/min

3.6.Oxygen saturation

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

3.7.BIS

BIS T1	98
BIS T2	95
BIS T3	98
BIS T4	98
BIS T5	88
BIS T6	63
BIS T7	74
BIS T8	74
BIS T9	68
BIS T10	76
BIS T11	98
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	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	83 min

Operation duration

83 min

4.7.Time-on

Time-on	12:20

Time-on

12:20

4.8.End time

End time	13:43

End time

13:43

4.9.Departure time

Departure time	13:55

Departure time

13:55

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	53.81 mg

Total dosage of dexmedetomidine

53.81 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	YES

Physical movement

YES

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	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