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	74 years old

2.2.Weight

Weight	60 kg

Weight

60 kg

2.3.Height

Height	1.61 m

Height

1.61 m

2.4.BMI

BMI	23.15 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	175 mmHg
Systolic pressure T2	159 mmHg
Systolic pressure T3	166 mmHg
Systolic pressure T4	158 mmHg
Systolic pressure T5	157 mmHg
Systolic pressure T6	157 mmHg
Systolic pressure T7	158 mmHg
Systolic pressure T8	156 mmHg
Systolic pressure T9	157 mmHg
Systolic pressure T10	155 mmHg
Systolic pressure T11	164 mmHg
Systolic pressure T12	154 mmHg
Systolic pressure T13	156 mmHg

3.2.Diastolic pressure

Diastolic pressure T1	84 mmHg
Diastolic pressure T2	75 mmHg
Diastolic pressure T3	83 mmHg
Diastolic pressure T4	81 mmHg
Diastolic pressure T5	78 mmHg
Diastolic pressure T6	79 mmHg
Diastolic pressure T7	80 mmHg
Diastolic pressure T8	81 mmHg
Diastolic pressure T9	83 mmHg
Diastolic pressure T10	85 mmHg
Diastolic pressure T11	85 mmHg
Diastolic pressure T12	91 mmHg
Diastolic pressure T13	91 mmHg

3.3.Mean arterial pressure

Mean arterial pressure T1	116 mmHg
Mean arterial pressure T2	103 mmHg
Mean arterial pressure T3	105 mmHg
Mean arterial pressure T4	106 mmHg
Mean arterial pressure T5	104 mmHg
Mean arterial pressure T6	108 mmHg
Mean arterial pressure T7	90 mmHg
Mean arterial pressure T8	96 mmHg
Mean arterial pressure T9	96 mmHg
Mean arterial pressure T10	97 mmHg
Mean arterial pressure T11	115 mmHg
Mean arterial pressure T12	112 mmHg
Mean arterial pressure T13	112 mmHg

3.4.Heart rate

Heart rate T1	57 times/min
Heart rate T2	57 times/min
Heart rate T3	60 times/min
Heart rate T4	57 times/min
Heart rate T5	55 times/min
Heart rate T6	54 times/min
Heart rate T7	51 times/min
Heart rate T8	49 times/min
Heart rate T9	47 mmHg
Heart rate T10	47 times/min
Heart rate T11	52 times/min
Heart rate T12	52 times/min
Heart rate T13	55 times/min

3.5.Respiratory rate

Respiratory rate T1	17 times/min
Respiratory rate T2	16 times/min
Respiratory rate T3	14 times/min
Respiratory rate T4	16 times/min
Respiratory rate T5	15 times/min
Respiratory rate T6	13 times/min
Respiratory rate T7	18 times/min
Respiratory rate T8	16 times/min
Respiratory rate T9	13 times/min
Respiratory rate T10	11 times/min
Respiratory rate T11	10 times/min
Respiratory rate T12	10 times/min
Respiratory rate T13	11 times/min

3.6.Oxygen saturation

Oxygen saturation T1	99 %
Oxygen saturation T2	99 %
Oxygen saturation T3	97 %
Oxygen saturation T4	99 %
Oxygen saturation T5	99 %
Oxygen saturation T6	99 %
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	99 %

3.7.BIS

BIS T1	98
BIS T2	85
BIS T3	97
BIS T4	89
BIS T5	86
BIS T6	93
BIS T7	89
BIS T8	91
BIS T9	97
BIS T10	97
BIS T11	87
BIS T12	98
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	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	84 min

Operation duration

84 min

4.7.Time-on

Time-on	12:30

Time-on

12:30

4.8.End time

End time	13:54

End time

13:54

4.9.Departure time

Departure time	14:10

Departure time

14:10

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	26

1 day preoperative STAI-S

5.5.1.5.1.2、Postoperative day STAI-S

Postoperative day STAI-S	22

Postoperative day STAI-S

5.2.

5.5.2.5.2.1、1 day preoperative MMSE

1 day preoperative MMSE	28

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