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	66 years old

2.2.Weight

Weight	75 kg

Weight

75 kg

2.3.Height

Height	1.75 m

Height

1.75 m

2.4.BMI

BMI	24.49 kg/m2

2.5.Degree of education

Degree of education	Primary school

Degree of education

Primary school

2.6.ASA

ASA	Ⅱ

ASA

Ⅱ

2.7.Underlying disease

Underlying disease	Hypertention / Diabetes

Underlying disease

Hypertention

Diabetes

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	155 mmHg
Systolic pressure T3	130 mmHg
Systolic pressure T4	152 mmHg
Systolic pressure T5	159 mmHg
Systolic pressure T6	149 mmHg
Systolic pressure T7	144 mmHg
Systolic pressure T8	133 mmHg
Systolic pressure T9	127 mmHg
Systolic pressure T10	124 mmHg
Systolic pressure T11	150 mmHg
Systolic pressure T12	165 mmHg
Systolic pressure T13	164 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	100 mmHg
Diastolic pressure T2	93 mmHg
Diastolic pressure T3	81 mmHg
Diastolic pressure T4	94 mmHg
Diastolic pressure T5	99 mmHg
Diastolic pressure T6	102 mmHg
Diastolic pressure T7	92 mmHg
Diastolic pressure T8	85 mmHg
Diastolic pressure T9	90 mmHg
Diastolic pressure T10	88 mmHg
Diastolic pressure T11	97 mmHg
Diastolic pressure T12	103 mmHg
Diastolic pressure T13	102 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	116 mmHg
Mean arterial pressure T2	115 mmHg
Mean arterial pressure T3	98 mmHg
Mean arterial pressure T4	104 mmHg
Mean arterial pressure T5	111 mmHg
Mean arterial pressure T6	123 mmHg
Mean arterial pressure T7	107 mmHg
Mean arterial pressure T8	99 mmHg
Mean arterial pressure T9	99 mmHg
Mean arterial pressure T10	98 mmHg
Mean arterial pressure T11	116 mmHg
Mean arterial pressure T12	123 mmHg
Mean arterial pressure T13	122 mmHg

3.4.Heart rate

Heart rate T1	65 times/min
Heart rate T2	63 times/min
Heart rate T3	63 times/min
Heart rate T4	59 times/min
Heart rate T5	55 times/min
Heart rate T6	56 times/min
Heart rate T7	53 times/min
Heart rate T8	51 times/min
Heart rate T9	49 mmHg
Heart rate T10	49 times/min
Heart rate T11	50 times/min
Heart rate T12	51 times/min
Heart rate T13	58 times/min

3.5.Respiratory rate

Respiratory rate T1	18 times/min
Respiratory rate T2	19 times/min
Respiratory rate T3	17 times/min
Respiratory rate T4	13 times/min
Respiratory rate T5	19 times/min
Respiratory rate T6	14 times/min
Respiratory rate T7	14 times/min
Respiratory rate T8	13 times/min
Respiratory rate T9	13 times/min
Respiratory rate T10	12 times/min
Respiratory rate T11	15 times/min
Respiratory rate T12	16 times/min
Respiratory rate T13	14 times/min

3.6.Oxygen saturation

Oxygen saturation T1	95 %
Oxygen saturation T2	97 %
Oxygen saturation T3	97 %
Oxygen saturation T4	99 %
Oxygen saturation T5	97 %
Oxygen saturation T6	96 %
Oxygen saturation T7	95 %
Oxygen saturation T8	96 %
Oxygen saturation T9	95 %
Oxygen saturation T10	94 %
Oxygen saturation T11	97 %
Oxygen saturation T12	97 %
Oxygen saturation T13	96 %

3.7.BIS

BIS T1	94
BIS T2	91
BIS T3	96
BIS T4	97
BIS T5	92
BIS T6	79
BIS T7	69
BIS T8	63
BIS T9	75
BIS T10	73
BIS T11	93
BIS T12	91
BIS T13	95

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	89 min

Operation duration

89 min

4.7.Time-on

Time-on	08:45

Time-on

08:45

4.8.End time

End time	11:14

End time

11:14

4.9.Departure time

Departure time	11:26

Departure time

11:26

4.10.Total dosage of dexmedetomidine

Total dosage of dexmedetomidine	55.5 mg

Total dosage of dexmedetomidine

55.5 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	23

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	16

1 day preoperative MMSE

5.5.2.5.2.2、Postoperative day MMSE

Poseoperative day MMSE	20

Poseoperative day MMSE

5.5.2.5.2.3、Postoperative 1-day MMSE

Postoperative 1-day MMSE	24

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