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	72 years old

2.2.Weight

Weight	80 kg

Weight

80 kg

2.3.Height

Height	1.70 m

Height

1.70 m

2.4.BMI

BMI	27.68 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	160 mmHg
Systolic pressure T2	135 mmHg
Systolic pressure T3	147 mmHg
Systolic pressure T4	149 mmHg
Systolic pressure T5	147 mmHg
Systolic pressure T6	135 mmHg
Systolic pressure T7	127 mmHg
Systolic pressure T8	133 mmHg
Systolic pressure T9	123 mmHg
Systolic pressure T10	126 mmHg
Systolic pressure T11	140 mmHg
Systolic pressure T12	140 mmHg
Systolic pressure T13	143 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	96 mmHg
Diastolic pressure T2	85 mmHg
Diastolic pressure T3	87 mmHg
Diastolic pressure T4	89 mmHg
Diastolic pressure T5	91 mmHg
Diastolic pressure T6	85 mmHg
Diastolic pressure T7	80 mmHg
Diastolic pressure T8	76 mmHg
Diastolic pressure T9	79 mmHg
Diastolic pressure T10	81 mmHg
Diastolic pressure T11	83 mmHg
Diastolic pressure T12	91 mmHg
Diastolic pressure T13	90 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	130 mmHg
Mean arterial pressure T2	104 mmHg
Mean arterial pressure T3	109 mmHg
Mean arterial pressure T4	114 mmHg
Mean arterial pressure T5	107 mmHg
Mean arterial pressure T6	95 mmHg
Mean arterial pressure T7	91 mmHg
Mean arterial pressure T8	96 mmHg
Mean arterial pressure T9	89 mmHg
Mean arterial pressure T10	96 mmHg
Mean arterial pressure T11	95 mmHg
Mean arterial pressure T12	99 mmHg
Mean arterial pressure T13	107 mmHg

3.4.Heart rate

Heart rate T1	86 times/min
Heart rate T2	82 times/min
Heart rate T3	88 times/min
Heart rate T4	76 times/min
Heart rate T5	75 times/min
Heart rate T6	77 times/min
Heart rate T7	70 times/min
Heart rate T8	70 times/min
Heart rate T9	68 mmHg
Heart rate T10	65 times/min
Heart rate T11	66 times/min
Heart rate T12	71 times/min
Heart rate T13	71 times/min

3.5.Respiratory rate

Respiratory rate T1	23 times/min
Respiratory rate T2	22 times/min
Respiratory rate T3	22 times/min
Respiratory rate T4	21 times/min
Respiratory rate T5	20 times/min
Respiratory rate T6	19 times/min
Respiratory rate T7	16 times/min
Respiratory rate T8	16 times/min
Respiratory rate T9	17 times/min
Respiratory rate T10	15 times/min
Respiratory rate T11	17 times/min
Respiratory rate T12	16 times/min
Respiratory rate T13	19 times/min

3.6.Oxygen saturation

Oxygen saturation T1	95 %
Oxygen saturation T2	92 %
Oxygen saturation T3	93 %
Oxygen saturation T4	98 %
Oxygen saturation T5	98 %
Oxygen saturation T6	94 %
Oxygen saturation T7	95 %
Oxygen saturation T8	95 %
Oxygen saturation T9	97 %
Oxygen saturation T10	97 %
Oxygen saturation T11	98 %
Oxygen saturation T12	97 %
Oxygen saturation T13	96 %

3.7.BIS

BIS T1	90
BIS T2	88
BIS T3	90
BIS T4	90
BIS T5	90
BIS T6	83
BIS T7	76
BIS T8	75
BIS T9	78
BIS T10	73
BIS T11	81
BIS T12	88
BIS T13	93

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	T8

Sensory blockade plane

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	80 min

Operation duration

80 min

4.7.Time-on

Time-on	16:45

Time-on

16:45

4.8.End time

End time	18:05

End time

18:05

4.9.Departure time

Departure time	18:11

Departure time

18:11

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	49.60 mg

Total dosage of dexmedetomidine

49.60 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	YES

Hypoxemia

YES

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	30

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